OT VERIO IQ METER
Report
- Report Number
- 2939301-2014-14905
- Event Type
- Injury
- Date Received
- June 19, 2014
- Report Date
- June 10, 2014
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K110637
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.
FOLLOW-UP # 2 ¿ (08/20/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON (B)(4) 2014 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.
FOLLOW-UP # 1 ¿ (07/08/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 6/25/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/26/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.
ON (B)(6) 2014, A PHARMACIST CONTACTED LIFESCAN (LFS) (B)(4) FOR THE LAY USER/PATIENT ALLEGING THE PATIENT¿S ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THIS COMPLAINT IS BEING CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVES (CSR) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED INACCURACY BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2014. AT 9:23 A. M. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF ¿112 MG/DL¿ WITH THE SUBJECT METER AND ¿82MG/DL¿ WITH ANOTHER DEVICE (VITA), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30%. IT IS NOT KNOWN WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE HER DIABETES. IT IS ALSO NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED INACCURATE READING(S) OBTAINED WITH THE SUBJECT METER. THE REPORTER MENTIONED, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS. THE REPORTER DOES NOT RECALL WHAT SYMPTOMS THE PATIENT DEVELOPED. AT AN UNSPECIFIED DATE/TIME, THE REPORTER STATED THAT THE PATIENT RECEIVED AN UNSPECIFIED TREATMENT FROM A HEALTH CARE PROFESSIONAL (HCP) AND REQUIRED ¿HOSPITALIZATION¿. THE REPORTER STATED THAT THE PATIENT¿S BLOOD GLUCOSE WAS TESTED WITH ANOTHER DEVICE; HOWEVER, THE REPORTER DID NOT PROVIDE THE ACTUAL READINGS OBTAINED. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER ALLEGEDLY SUFFERED SYMPTOMS INDICATIVE OF A SERIOUS INJURY WHILE USING THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360130 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3573156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |