MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® PERFORMA TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	07299702001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged that the clinical picture was not matching with the glucose results for 1 patient tested on accu-chek performa meter serial number: (b)(4) compared to another meter.On (b)(6) 2023 at 3:13 p.M.The accu-chek performa meter result was 530 mg/dl.Later in the day, the patient was taken to the er and at 4:31 p.M.The er's meter result was reported as 96 mg/dl.The reporter stated that both level 1 and level 2 controls were ran on the morning of on (b)(6) 2023 and they both passed.
Additional Manufacturer Narrative
The meter was advised to be replaced and the test strips were requested for investigation.The meter (serial number: (b)(4) was received for investigation.The test strips were not returned.The meter was tested with retention strips and retention controls: control ranges: level 1: 30-60 mg/dl, level 2: 261-353 mg/dl.Results: level 1 ¿ 45, 46, and 45 mg/dl, level 2 ¿ 314, 312, and 305 mg/dl.All returned results are within acceptable range.No information was provided in the complaint case that would point to a cause for the result discrepancy.On a regular basis, inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ACCU-CHEK ® PERFORMA TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16495070
• Report Number: 1823260-2023-00700
• Device Sequence Number: 6315948
• Product Code: LFR
• UDI-Device Identifier: 00365702602106
• UDI-Public: 00365702602106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 07299702001
• Device Lot Number: 670530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown