OneTouch Verio IQ 022-267Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00353885007702), received between Nov 29, 2016 and Dec 6, 2018 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Component Missing” (27 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2018Component Missing; Component Missing

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO IQ METER KIT WAS MISSING AN ADAPTER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE TO SPECIFY WHEN SHE FIRST NOTICED THAT THE METER ADAPTER WAS MISSING. THE PATIENT MANAGES HER DIABETES WITH A SELF-ADJUSTED DOSE OF INSULIN (USUAL DOSE 22 UNITS) AND REPORTED THAT DUE TO THE PRODUCT ISSUE SHE HAD TO GUESS HOW MUCH INSULIN TO TAKE. THE PATIENT REPORTED THAT AN UNKNOWN TIME AFTER THE PRODUCT ISSUE FIRST BEGAN SHE DEVELOPED A SYMPTOM OF FEELING ¿SHAKY¿. THE PATIENT REPORTED SELF-TREATING THIS SYMPTOMS WITH JUICE AND TAKING A CANDY. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE CLOSURE SEAL ON THE PACKAGING WAS INTACT PRIOR TO OPENING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER BEING UNABLE TO CHARGE HER METER DUE TO THE AC ADAPTOR BEING MISSING FROM HER VERIO IQ METER KIT.

  Patient problems: Shaking/Tremors

  MAUDE report 8136697 ↗
• MalfunctionDec 4, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿431, 374 AND 248 MG/DL ¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. 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 7078269 ↗
• MalfunctionApr 26, 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 6521508 ↗
• MalfunctionApr 25, 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 6517781 ↗
• MalfunctionApr 23, 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 6514922 ↗
• MalfunctionApr 19, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT HARDWARE WAS MISSING FROM HER ONETOUCH VERIOIQ METER KIT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ABOUT 6 MONTHS PRIOR TO CONTACTING LFS, SHE HAD NOT RECEIVED THE USB CABLE/AC ADAPTOR WITH THE ONETOUCH VERIOIQ STARTER KIT. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISE. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE FOLLOWING THE START OF THE ALLEGED ISSUE. SHE REPORTED THAT ONE MORNING, 5 DAYS PRIOR TO CONTACTING LFS, SHE DEVELOPED SYMPTOMS OF ¿DIZZY, WEAK, FEELS LIKE WILL PASS OUT AND HEADACHE¿. SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED WITH THE PATIENT THAT THE CLOSURE SEAL ON THE PACKAGING HAD BEEN INTACT PRIOR TO OPENING. THE CCA EDUCATED THE PATIENT ON THE CORRECT BOX CONTENTS AND THE PATIENT REPORTED THAT THE USB CABLE/AC ADAPTOR HAD BEEN MISSING FROM THE STARTER KIT. THE ISSUE REMAINED UNRESOLVED. THE PATIENT¿S PRODUCTS WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENT PRODUCTS, INCLUDING A CABLE AND ADAPTOR, WE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6502681 ↗
• MalfunctionApr 14, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR UNKNOWN. 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 6492779 ↗
• MalfunctionApr 5, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR 4. 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 6459480 ↗
• MalfunctionMar 26, 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 6434858 ↗
• MalfunctionMar 26, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE ERRATIC RESULTS. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE RESULTS OF 143, 150 AND 350MG/DL ON THE SUBJECT METER WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. 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 6434729 ↗
• MalfunctionMar 12, 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 6398252 ↗
• MalfunctionMar 7, 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 6383152 ↗
• MalfunctionMar 7, 2017Loss of Power; Loss of Power

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING UNIT POWERS OFF DURING USE. 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 6383140 ↗
• MalfunctionMar 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR 3. 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 6383136 ↗
• MalfunctionMar 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR 4. 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 6383134 ↗
• MalfunctionMar 3, 2017Device Alarm System; Device Alarm System

  ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING APPLY SAMPLE. 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 6375511 ↗
• MalfunctionFeb 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 6348510 ↗
• MalfunctionFeb 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 6344776 ↗
• MalfunctionFeb 11, 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 6324714 ↗
• MalfunctionFeb 7, 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 6306552 ↗
• MalfunctionFeb 7, 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 6306511 ↗
• MalfunctionJan 26, 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 6278511 ↗
• MalfunctionJan 26, 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 6278506 ↗
• MalfunctionJan 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 6272330 ↗
• MalfunctionJan 23, 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 6269261 ↗

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