MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO REFLECT METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4785142

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Vertigo (2134); Vomiting (2144); Lethargy (2560); Dry Mouth (4485)

Event Date 07/03/2022

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.The reported issue has been investigated.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.

Event Description

On (b)(6) 2022.The lay user/patient contacted lifescan (lfs), alleging that her onetouch verio reflect meter was displaying an error message of ¿error 4¿.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained after customer care (cc) listened to the call recording as the patient was unable to be reached by phone for follow-up questions.The patient reported that the alleged error messages began to appear in the morning of (b)(6) 2022.The patient manages her diabetes with pills and diet and/or exercise (metformin up to 500 mg, 4 to 5 times a day) and stated that she skipped 2 doses due to the alleged issue.The patient also indicated that due to the subject meter displaying errors, she felt so stressed and didn¿t make any changes in her medication as she usually would have done depending on her readings.The patient claimed that around midday on (b)(6) 2022 she started developing symptoms of ¿feeling weak, dizzy, dry mouth, vomiting, low blood pressure (88/44) and lack of energy¿.The patient was ¿unconscious¿ for around 12 hours, then her husband woke her up around midnight and treated her with chicken soup and she was able to take her metformin.The patient reported that after treatment around midnight, she obtained a blood glucose reading of ¿200 mg/dl¿ on another unspecified meter.At the time of troubleshooting, the customer care agent (cca) noted the subject meter was not being used for the first time.The cca walked the patient through a test and ¿error 2¿ appeared on the subject meter.The cca educated the patient on what error 2 and 4 mean and about storage of the test strips.The cca completed troubleshooting with a new vial and the patient was able to receive a reading.The cca established that the errors were caused by the test strips.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

• Brand Name: OT VERIO REFLECT METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 15009247
• MDR Text Key: 295860930
• Report Number: 3008382007-2022-04326
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K193475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4785142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female