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

Model Number	023-927
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Diaphoresis (2452); Shaking/Tremors (2515)
Date of Event	12/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition, 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.
Event or Problem Description
On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) italy, alleging that her onetouch verio reflect meter read inaccurately high compared to another device (right meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began around 10 days prior to contacting lfs.The patient reported obtaining blood glucose readings of ¿150, 250 and 130 mg/dl¿ with the subject meter compared to ¿90, 170 and 66 mg/dl¿ respectively on the other device.The comparative results were obtained within 30 minutes of each other.The patient manages her diabetes with insulin three times a day on a self-adjusting dose.It was not reported if the patient made any changes to her usual diabetes management regimen as a result of the alleged issue.The patient reported that she started to ¿tremble and sweat¿ on (b)(6) 2021 at 11:55 pm.The patient claimed she treated herself with sugar at the onset of symptoms.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted an approved sample site was used for testing and the correct testing process was being followed.The cca confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted the patient did not have control solution to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition, 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.
Event or Problem Description
On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch verio reflect meter read inaccurately high compared to another device (right meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began around 10 days prior to contacting lfs.The patient reported obtaining blood glucose readings of ¿150, 250 and 130 mg/dl¿ with the subject meter compared to ¿90, 170 and 66 mg/dl¿ respectively on the other device.The comparative results were obtained within 30 minutes of each other.The patient manages her diabetes with insulin three times a day on a self-adjusting dose.It was not reported if the patient made any changes to her usual diabetes management regimen as a result of the alleged issue.The patient reported that she started to ¿tremble and sweat¿ on (b)(6) 2021 at 11:55 pm.The patient claimed she treated herself with sugar at the onset of symptoms.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted an approved sample site was used for testing and the correct testing process was being followed.The cca confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted the patient did not have control solution to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.
Additional Manufacturer Narrative
The lay user/patient¿s meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.Further analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT VERIO REFLECT METER
• Common Device Name: 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: 13057211
• Report Number: 3008382007-2021-04282
• Device Sequence Number: 17131533
• Product Code: NBW
• UDI-Device Identifier: 00353885011693
• UDI-Public: 00353885011693
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K193475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 023-927
• Device Lot Number: 4661271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown