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

Model Number 023-271

Device Problem Device Handling Problem (3265)

Patient Problems Anxiety (2328); Diaphoresis (2452); Shaking/Tremors (2515)

Event Date 07/04/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch verio flex meter was reading inaccurately high compared to another meter and to her feelings/usual readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after the medical surveillance specialist (mss) reviewed the call recording.The patient alleged that the issue began on (b)(6) 2022, at midnight.The patient stated that she received a blood glucose reading of ¿130 mg/dl¿ on the subject meter before going to bed and compared it to a reading of ¿77 mg/dl¿ on a freestyle meter, taken more than 30 minutes apart from each other.The patient informed the cca that the subject meter always reads approximately 20 points higher than her freestyle meter.The patient manages her diabetes with pills (glimepiride 2 mg) and exercise and claimed that she decreased her dose of medication to 1 mg since the beginning of (b)(6) 2022, in response to the high readings.The patient stated that since the alleged issue started, she suffered several low blood glucose events with symptoms of ¿shaking, night sweats and anxiety¿ from (b)(6) 2022 onwards.The patient denied receiving any medical treatment for the reported symptoms.During troubleshooting, the cca noted that the subject meter was set to the correct unit of measure and the patient had followed the correct testing process.The cca confirmed that the patient¿s test strips had been stored correctly, were within expiry date and the test strip vial was not cracked or broken.The cca walked through a control solution test and concluded that the result was in range with a reading of ¿125 mg/dl¿.The cca educated the patient on the use of control solution.Replacement products have been sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event while using the product.The subject meter could not be ruled out as a cause or contributor to the event.

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.

• Brand Name: OT VERIO FLEX 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: 15307440
• MDR Text Key: 298776076
• Report Number: 3008382007-2022-04338
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 4840606
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2022
• 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