OneTouch Verio IQ 022-268Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00353885007719), received between Nov 24, 2016 and Nov 11, 2017 — classified as 3 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Component Missing” (41 reports).

1 other recall cover devices cleared under the same FDA submission (K110637); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE ERRATIC RESULTS ON THE SUBJECT METER OF "452, 173, 137, 149 AND 101 MG/DL", PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023410 ↗
• InjuryNov 4, 2017Component Missing; Component Missing

  ON (B)(6), A REPORTER FOR THE PATIENT CONTACTED LIFESCAN (LFS) USA, TO REPORT THAT HARDWARE MAY HAVE BEEN MISSING FROM THE PATIENT¿S ONETOUCH VERIOIQ STARTER KITS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED WHEN THE REPORTER WAS CONTACTED WITH FOLLOW-UP QUESTIONS. THE REPORTER STATED THAT THE PATIENT OBTAINED TWO ONETOUCH VERIOIQ STARTER KITS AT 4PM ON EITHER (B)(6). SHE STATED THAT THE USB CABLE AND AC ADAPTOR MAY NOT HAVE BEEN INCLUDED WITH THE KITS; SHE INDICATED THAT THE KITS WERE SEALED AND SHE WAS UNSURE IF THE HARDWARE WAS LOST, OR HAD BEEN MISSING FROM THE KITS. THE PATIENT MANAGES HER DIABETES WITH INSULIN WHICH SHE SELF-ADJUSTS. THE REPORTER DENIED THAT THE PATIENT HAD MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER THE START OF THE ALLEGED ISSUE. SHE REPORTED THAT BECAUSE THE PATIENT WAS UNABLE TO CHARGE THE METER AND OBTAIN A BLOOD GLUCOSE RESULT, SHE DEVELOPED SYMPTOMS OF ¿TIREDNESS AND RESPIRATION PROBLEMS¿ WHICH THE REPORTER ASSOCIATED WITH A HIGH BLOOD GLUCOSE EXCURSION. SHE REPORTED THAT THE PATIENT WAS TAKEN TO HOSPITAL WHERE SHE RECEIVED TREATMENT OF LANTUS AND HUMALOG I

  Patient problems: Dyspnea; Fatigue

  MAUDE report 7001981 ↗
• InjuryNov 4, 2017Component Missing; Component Missing

  ON (B)(6), A REPORTER FOR THE PATIENT CONTACTED LIFESCAN (LFS) USA, TO REPORT THAT HARDWARE MAY HAVE BEEN MISSING FROM THE PATIENT¿S ONETOUCH VERIOIQ STARTER KITS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED WHEN THE REPORTER WAS CONTACTED WITH FOLLOW-UP QUESTIONS. THE REPORTER STATED THAT THE PATIENT OBTAINED TWO ONETOUCH VERIOIQ STARTER KITS AT 4PM ON EITHER (B)(6). SHE STATED THAT THE USB CABLE AND AC ADAPTOR MAY NOT HAVE BEEN INCLUDED WITH THE KITS; SHE INDICATED THAT THE KITS WERE SEALED AND SHE WAS UNSURE IF THE HARDWARE WAS LOST, OR HAD BEEN MISSING FROM THE KITS. THE PATIENT MANAGES HER DIABETES WITH INSULIN WHICH SHE SELF-ADJUSTS. THE REPORTER DENIED THAT THE PATIENT HAD MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER THE START OF THE ALLEGED ISSUE. SHE REPORTED THAT BECAUSE THE PATIENT WAS UNABLE TO CHARGE THE METER AND OBTAIN A BLOOD GLUCOSE RESULT, SHE DEVELOPED SYMPTOMS OF ¿TIREDNESS AND RESPIRATION PROBLEMS¿ WHICH THE REPORTER ASSOCIATED WITH A HIGH BLOOD GLUCOSE EXCURSION. SHE REPORTED THAT THE PATIENT WAS TAKEN TO HOSPITAL WHERE SHE RECEIVED TREATMENT OF LANTUS AND HUMALOG I

  Patient problems: Dyspnea; Fatigue

  MAUDE report 7001976 ↗
• MalfunctionMay 6, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR 2. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6549948 ↗
• MalfunctionMay 5, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6546775 ↗
• MalfunctionApr 30, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6533084 ↗
• MalfunctionApr 28, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING MISSING PRODUCT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6530988 ↗
• MalfunctionApr 15, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6495912 ↗
• MalfunctionApr 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING UNUSUAL ISSUE - METER OVERHEATS WHEN PLUGGED IN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6492634 ↗
• InjuryApr 7, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH, COMPARED TO ANOTHER METER (ONETOUCH ULTRA 2). THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, AND FURTHER INFORMATION OBTAINED WHEN MEDICAL SURVEILLANCE SPECIALIST REVIEWED THE INITIAL CALL. THE PATIENT REPORTED THAT HE FIRST BECAME AWARE OF THE ALLEGED METER ISSUE BEGAN ON (B)(6), AT 3.15 PM, ALLEGING THAT HE OBTAINED AN INACCURATELY HIGH BLOOD GLUCOSE READING OF ¿192 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿88 MG/DL¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. THE PATIENT REPORTED THAT HE MANAGES HIS DIABETES USING INSULIN (SELF-ADJUSTER) AND HE MADE NO CHANGES TO HIS NORMAL DIABETES MANAGEMENT REGIMEN. THE PATIENT REPORTED THAT TEN MINUTES PRIOR TO HIM BECOMING AWARE OF THE ALLEGED METER ISSUE HE HAD DEVELOPED SYMPTOMS OF ¿BLURRED VISION, SHAKY AND WEAK¿, IN R

  Patient problems: Shaking/Tremors; Visual Impairment; Weakness

  MAUDE report 6471104 ↗
• MalfunctionApr 6, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6463065 ↗
• MalfunctionApr 2, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6452388 ↗
• MalfunctionMar 30, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6445299 ↗
• MalfunctionMar 30, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING PACKAGING ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6445293 ↗
• MalfunctionMar 28, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6438188 ↗
• MalfunctionMar 23, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN, USA ALLEGING HARDWARE MISSING (USB CABLE/AC ADAPTOR) FROM THE ONETOUCH VERIOIQ STARTER KIT. THE SEAL FROM THE BOX HAD BEEN OPENED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6427809 ↗
• MalfunctionMar 22, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6423549 ↗
• MalfunctionMar 21, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6420015 ↗
• MalfunctionMar 18, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR 1. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6415769 ↗
• MalfunctionMar 10, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BLOOD READING AS CONTROL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6394321 ↗
• MalfunctionMar 9, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6390551 ↗
• MalfunctionMar 8, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6386685 ↗
• MalfunctionMar 7, 2017Low Battery; Low Battery

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING BATTERY CHARGE ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6383214 ↗
• MalfunctionMar 5, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6379501 ↗
• MalfunctionFeb 24, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING HARDWARE MISSING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6355813 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110637. One submission often covers many models, so check the product and lot details in each record.

• Z-1359-2012 · Feb 21, 2012 · Terminated
  OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warrant