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

Catalog Number 05942861001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

The test strips, meters a and b were received for investigation.The test strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.There was no obvious reagent discoloration.Meter a and the returned test strips were tested using retention controls.Test results: level 1 ¿ 44, 44, and 44 mg/dl (qc range 30-60 mg/dl).Level 2 ¿ 308, 305, and 307 mg/dl (qc range 261-353 mg/dl).Meter b was tested using retention strips and retention controls.Test results: level 1 ¿ 43, 45, and 45 mg/dl (qc range 30-60 mg/dl).Level 2 ¿ 298, 294, and 299 mg/dl (qc range 261-353 mg/dl).All returned results were within acceptable range.The log files of both meters did not indicate any hardware or software issues that would lead to a measurement discrepancy.Meters a and b were disassembled for further investigation.There were no damages or contamination observed.On a regular basis, accu-chek 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 is ongoing.

Event Description

We received an allegation of questionable glucose results for 1 patient tested with accu-chek inform ii meter with serial number (b)(6) (meter a) when compared to another accu-chek inform ii meter with serial number (b)(6) (meter b) and the laboratory.The reporter stated that they performed the laboratory test and the comparison with meter b because they did not believe the results from meter a.The result from meter a at 1:26 am was 33 mg/dl.The laboratory result at 1:34 am was 87 mg/dl.The result from meter a at 7:54 am was 41 mg/dl.The result from meter b at 7:57 am was 61 mg/dl.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The vial's details were scanned; no issues were noted.The vial's integrity was tested; the result was acceptable.The investigation determined that the primary packaging seal of the vial was acceptable.

• Brand Name: ACCU-CHEK INFORM II TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17673814
• MDR Text Key: 322544305
• Report Number: 1823260-2023-02871
• Device Sequence Number: 1
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05942861001
• Device Lot Number: 670237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPICILLIN; GENTAMICIN
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Weight: 2 KG