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	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant glucose results for one patient tested with accu-chek performa meter serial number (b)(4).At 3:20 p.M., a sample from the patient was tested using the meter, resulting in a glucose value of 245 mg/dl.The patient was feeling shaking, so the doctor requested an hba1c test for the patient.Within 8 minutes, the hba1c test came back normal.At 3:31 p.M., a sample from the patient was tested using the meter, resulting in a glucose value of 129 mg/dl.At 3:33 p.M., a sample from the patient was tested using the meter, resulting in a glucose value of 90 mg/dl.The reporter stated the patient recently had a spray tan and it was on her hands during time of sample collection.Controls tested on the meter on the day of the event were within range.The customer continued to run controls on the meter until (b)(6) 2022 and all controls passed.
Additional Manufacturer Narrative
The customer's meter and test strips were requested for investigation.The meter and test strips were returned for investigation.The test strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.There was no obvious reagent discoloration.Investigation of the test strips is ongoing.The returned meter was tested using retention test strips and retention controls.Returned meter testing results: control ranges: level 1: 30-60 mg/dl.Level 2: 261-353 mg/dl.Results: level 1: 45 mg/dl, 45 mg/dl, 43 mg/dl.Level 2: 301 mg/dl, 303 mg/dl, 305 mg/dl.On a regular basis, accu-chek performa strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.
Additional Manufacturer Narrative
Upon further investigation of the returned test strips, the test strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.There was no obvious reagent discoloration.Testing was performed using glycolyzed blood and was within specifications.The vial integrity of the returned vial was tested and passed.As the primary packaging seal was acceptable for the returned vial, there is evidence to support that the returned product was appropriately sealed.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14693207
• Report Number: 1823260-2022-01728
• Device Sequence Number: 6693112
• 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,Followup
• Report Date (Section B): 09/30/2022

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: 11/30/2022
• Device Catalogue Number: 07299702001
• Device Lot Number: 480127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 10/01/2022
• 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: Female