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

Catalog Number	07299702001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is a lay user/patient.The meter and test strips were requested for investigation.The product has not been received at this time.A routine retention testing process has been implemented for all strip lots currently valid in the market.All retention data is reviewed on a monthly basis and appropriate actions are taken as needed.
Event or Problem Description
There was a complaint of discrepant glucose results for one patient tested with accu-chek performa meter with an unknown serial number.The result from the meter was 200 mg/dl.The result from the meter was 110 mg/dl.The timing between tests was within ten minutes.
Additional Manufacturer Narrative
Field h3 updated.Since no product was returned, 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
• MDR Report Key: 12474422
• Report Number: 1823260-2021-02692
• Device Sequence Number: 11665941
• 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
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: Lay User/Patient
• Device Catalogue Number: 07299702001
• Device Lot Number: 479457
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1