i-STAT 04P75-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00054749000340), received between Feb 10, 2017 and Nov 21, 2023 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (22 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON 01-NOV-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT THE RECHARGEABLE BATTERY SOMETIMES GETS HOT, AND CODE 86 FREQUENTLY OCCURS WHILE USING I-STAT 1 ANALYZER SN (B)(6). THE ANALYZER WERE REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181157 ↗
• MalfunctionOct 3, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON 27-SEP-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT SMOKE WAS COMING OUR OF BATTERY COMPARTMENT AND FROM BARCODE SCANNER AREA OF I-STAT 1 ANALYZER (B)(6). CUSTOMER IS NOT USING ABBOTT RECOMMENDED BATTERIES (CURRENTLY CUSTOMER IS USING 9 VOLT NIPPON AND UNIROS BATTERIES). THE ANALYZER WILL REPAIRED AND RETURNED TO THE CUSTOMER. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, USING BATTERIES WITH CARRIER WITH RED FUSED CARRIER AT THE TIME OF THE EVENT. THEREFORE, THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH, FAILING SAFE. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860454 ↗
• MalfunctionSep 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER SN (B)(6) WAS BURNED, UNABLE TO BOOT. THE ANALYZER WAS RETURNED TO FLEXTRONICS, SINGAPORE FOR REPAIR. THERE WAS NO EXTERNAL DAMAGE TO THE ANALYZER, NOR EVIDENCE OF BURN ON THE EXTERIOR. DURING ANALYSIS THE CAPACITOR C26 WAS FOUND BURNT. ON 17-SEP-2023 APOC BECAME AWARE THE CUSTOMER EXPERIENCED VISUAL SMOKE COMING FROM THE ANALYZER. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, USING I-STAT RECHARGEABLE BATTERIES AT THE TIME OF THE EVENT. THEREFORE, THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH, FAILING SAFE. THE WAS REPAIRED AND RETURNED TO THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774757 ↗
• MalfunctionSep 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NEW INFORMATION: CUSTOMER PROVIDED PATIENT INFORMATION, MEDICATION, ANALYZER PRODUCT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773158 ↗
• MalfunctionJun 27, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER SN (B)(6) BECAME HOT TO THE TOUCH AND IS NOT POWERING ON. THERE WAS NO SMOKE ASSOCIATED WITH THE EVENT. THE PRODUCT WAS REPLACED AT NO CHARGE. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH, FAILING SAFE. THE PRODUCT WAS REPLACED AND IS BEING RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209346 ↗
• MalfunctionMar 29, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2022, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED OBSERVING SMOKE COMING FROM I-STAT ANALYZER SN-(B)(4) DURING OPERATION. THE CUSTOMER REMOVED THE BATTERY FROM THE ANALYZER AND NOTICED IT WAS HOT TO TOUCH. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO INJURIES REPORTED. THE ANALYZER AND RECHARGEABLE PACK WERE REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. THE ANALYZER WAS OPERATING ON RECHARGEABLE BATTERIES AT THE TIME OF THE EVENT. AT THIS TIME THERE IS NO REASON TO BELIEVE PRODUCT WILL BECOME HOT TO THE TOUCH. THE PRODUCT WAS REPLACED AND RETURNING FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13940480 ↗
• MalfunctionMar 16, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2022, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED OBSERVING SMOKE COMING FROM THE COMPARTMENT OF I-STAT ANALYZER SN (B)(4) DURING OPERATION. THE PRODUCT DID NOT BECOME HOT TO THE TOUCH. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO INJURIES REPORTED. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. THE ANALYZER WAS OPERATING ON RECHARGEABLE BATTERIES AT THE TIME OF THE EVENT. AT THIS TIME THERE IS NO REASON TO BELIEVE PRODUCT WILL BECOME HOT TO THE TOUCH. THE PRODUCT WAS REPLACED AND RETURNING FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789987 ↗
• MalfunctionFeb 22, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2022, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER SN (B)(4) GENERATED A QUALITY CHECK CODE 86 DURING OPERATION. THE ROOM TEMPERATURE IS CONSTANT 24 HOURS A DAY, BUT ERROR 86 OCCURRED. CUSTOMER REPORTED THAT WHEN THEY REMOVED THE RECHARGEABLE BATTERY TO ACCLIMATIZE IT TO ROOM TEMPERATURE, IT WAS HOT. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO INJURIES REPORTED. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. THE ANALYZER WAS OPERATING ON RECHARGEABLE BATTERIES AT THE TIME OF THE EVENT. AT THIS TIME THERE IS NO REASON TO BELIEVE PRODUCT WILL BECOME HOT TO THE TOUCH. THE PRODUCT WAS REPLACED AND RETURNING FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577942 ↗
• MalfunctionNov 11, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON 04-NOV-2021, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED OBSERVING SMOKE COMING FROM THE COMPARTMENT OF I-STAT ANALYZER SN (B)(4) DURING OPERATION. THE PRODUCT DID NOT BECOME HOT TO THE TOUCH. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO INJURIES REPORTED. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. THE ANALYZER WAS OPERATION ON RECHARGEABLE BATTERIES. AT THIS TIME THERE IS NO REASON TO BELIEVE PRODUCT WILL BECOME HOT TO THE TOUCH. THE PRODUCT WAS REPLACED AND RETURNING FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800424 ↗
• MalfunctionOct 13, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625514 ↗
• MalfunctionJul 8, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136774 ↗
• MalfunctionMay 18, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON 13-MAY-2021, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED OBSERVING SMOKE COMING FROM THE BATTERY COMPARMENT AREA OF ANALYZER SN (B)(4). THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. A GREEN BATTERY CARRIER IS IN THE I-STAT 1 ANALYZER AT THE TIME OF THE EVENT. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. IN THIS CASE THE CUSTOMER STATED A GREEN (NON-FUSED) BATTERY CARRIER IS IN THE I-STAT 1 ANALYZER. THE CUSTOMER WAS ADVISED OF THE USE ERROR IN USING DISCONTINUED PRODUCT. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840903 ↗
• MalfunctionJan 26, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON 22-JAN-2021, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(4) SMOKE BURN WAS SEEN IN THE BATTERY COMPARTMENT AREA OF THE ANALYZER. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. CARRIER INFORMATION WAS NOT AVAILABLE. HOWEVER, THE ANALYZER SHIPPED ON 07-DEB-20212 WITH DISPOSABLE ALKALINE 9V DURACELL BATTERIES AND A RED CARRIER. THERE IS NO REASON TO SUSPECT THE PRODUCT WOULD BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231121 ↗
• MalfunctionJan 12, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON 31-DEC-2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT EQUIPMENT IS BURNT. THE CUSTOMER STATED THAT I-STAT1 (SN (B)(4)), HAVE MARKS ON/NEAR CONTACTS THAT APPEARED TO BE BURNT OR CORROSION AS DESCRIBED. THE CUSTOMER REPORTS ALL EQUIPMENT IS OPERATIONAL BUT WAS TAKEN OUT OF USE WHEN BURNT/CORROSION WAS NOTICED. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE ARE NO REPORTS OF FIRE, SMOKE OR BURNING AS THE EQUIPMENT WAS OPERATIONAL. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. CUSTOMER USING RECHARGEABLE BATTERIES. THERE IS NO REASON TO BELIEVE PRODUCT WILL BECOME HOT TO THE TOUCH. CUSTOMER STATES THE PRODUCT WAS OPERATIONAL AT THE TIME OF THE EVENT. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154425 ↗
• MalfunctionDec 23, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2020, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(4) THAT DID NOT ACTIVATE AND ALSO EMITTED SMOKE. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER USED DISPOSABLE ALKALINE 9V (B)(6) BATTERIES WITH RED CARRIER. THERE IS NO REASON TO SUSPECT THE PRODUCT WOULD BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11064404 ↗
• MalfunctionDec 23, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11064402 ↗
• MalfunctionDec 11, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER (B)(4) BECAME HOT TO TOUCH DURING A SOFTWARE DOWNLOAD. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Patient Involvement

  MAUDE report 9450409 ↗
• MalfunctionJul 10, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER (B)(4) WOULD NOT TURN ON. WHEN THE RECHARGEABLE BATTERY WAS REMOVED, THE ANALYZER WAS VERY HOT, AND THE CUSTOMER COULD SMELL A BURNING ODOR. THE CUSTOMER ALSO TRIED TO USE THE SAME ANALYZER WITH REGULAR BATTERIES, BUT THE SAME PROBLEM HAPPENED, AND THE ANALYZER WOULD NOT ACTIVATE. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Patient Involvement

  MAUDE report 8775430 ↗
• MalfunctionMay 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER SN (B)(4) WOULD NOT ACTIVATE. THE CUSTOMER REPORTS THAT CUSTOMER IS USING RECHARGEABLE BATTERIES AND DISPOSABLE 9 VOLT LITHIUM BATTERIES. THE ANALYZER WAS REPLACED AT NO CHARGE. THE ANALYZER WAS RETURNED FOR FAILURE ANALYSIS AND ON 05/15/2019 IT WAS DETERMINED THAT THE CAUSE FOR THE ANALYZER NOT ACTIVATING WAS DUE TO COMPONENT FAILURE, C4 CAPACITOR. ON 05/15/2019 THE CUSTOMER STATED THAT THEY ARE USING LITHIUM BATTERIES WITH A GREEN BATTERY CARRIER. APOC TECHNICAL SUPPORT EMAILED THE CUSTOMER AND ADVISED TO DISPOSE OF THE GREEN BATTERY CARRIER. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. REFER TO APOC PRODUCT ACTION APOC30AUG2010: IN SEPTEMBER 2010, APOC BEGAN COMMUNICATING INFORMATION CONCERNING I-STAT1 HANDHELD DISPOSABLE BATTERIES THAT HAVE THE POTENTIAL TO OVERHEAT DUE TO A CIRCUITRY FAILURE. THIS FAILURE CAN CAUSE THE HANDHELD TO BECOME UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPAR

  Patient problems: No Patient Involvement

  MAUDE report 8631144 ↗
• MalfunctionNov 15, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NA.

  Patient problems: No Patient Involvement

  MAUDE report 8073486 ↗
• MalfunctionAug 16, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED VISIBLE SMOKE COMING FROM I-STAT1 ANALYZER (B)(4) AFTER PLACING IT ON THE DOCKING STATION. THE CUSTOMER STATES THE ANALYZER WAS DROPPED, SENT TO THE BIO MED DEPARTMENT WHERE BATTERY WAS CHECKED AND THEN PLACED IN THE DOCKING STATION I-STAT DOWNLOADER RECHARGER NETWORK AND IT CAME ON. THE CUSTOMER REPORTS HE TRIED TO POWER ON THE ANALYZER AGAIN AND IT WOULD NOT POWER ON. IT WAS PLACED ON THE DOCKING STATION THE SHUT OFF. CUSTOMER REPORTS THE NEXT MORNING HE ATTEMPTED TO PLACE THE DOWNLOADER ON THE DOCKING STATION AND IT STARTED TO SMOKE. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION

  Patient problems: No Patient Involvement

  MAUDE report 7789423 ↗
• MalfunctionOct 10, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT1 ANALYZER SN (B)(4) THAT HAD LOWER RESULTS ON NA, K, CL, TCO2, ICA, BUN, AND HCT WHEN COMPARED TO SECOND I-STAT1 AND/OR VISTA ON TWO PATIENTS. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC, HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE ((B)(4).

  Patient problems: No Information

  MAUDE report 6938653 ↗
• MalfunctionOct 10, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT1 ANALYZER (B)(4) THAT HAD LOWER RESULTS ON K AND NA ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THERE WAS NO REPEAT ON I-STAT. NO REPLY FROM THE CUSTOMER. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TEST: NA, I-STAT: 121, CHEMISTRY MACHINE: 140; TEST: K, I-STAT: >9, CHEMISTRY MACHINE: 5.0. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC, HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE (B)(4).

  Patient problems: No Information

  MAUDE report 6938652 ↗
• MalfunctionOct 10, 2017Use of Device Problem; Use of Device Problem

  ON (B)(6) 2016, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT1 ANALYZERS SN (B)(4) USING THE SAME CUSTOMIZATION DID NOT FLAG A 6.0 K+ THE SAME, SN (B)(4) FLAGGED A 6.0 K+ AND SN (B)(4) DID NOT. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. APOC TECHNICAL SUPPORT SPECIALIST (TSS) ASSISTED THE CUSTOMER PER CUSTOMIZATION ART: (B)(4): TSS FOUND THAT THE CUSTOMER WAS NOT TAKING THE ROUNDING ISSUE INTO CONSIDERATION WHEN SHE ENTERED THE ACTION LIMITS, SHE HAD 6.0 AS THE UPPER LIMIT. TSS EXPLAINED TO THE CUSTOMER THAT IF SHE WANTED TO FLAG A 6.0 OR ABOVE SHE NEED TO ENTER 5.94 AS THE UPPER LIMIT. CUSTOMER REVISED ALL ACTION LIMITS TO TAKE THE ROUNDING ISSUE INTO CONSIDERATION. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC, HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE ((B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6938650 ↗
• MalfunctionOct 9, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED UNEXPECTED RESULTS ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE (B)(4).

  Patient problems: No Information

  MAUDE report 6932451 ↗