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

Catalog Number 05942861001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

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

Event Date 12/19/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable glucose results from an accu-chek inform ii meter.The meter result was 413 mg/dl at 1:09 pm.The meter result was 140 mg/dl at 1:16 pm.This result was believed to be correct.

Manufacturer Narrative

The meter serial number is (b)(6).The customer had not performed qc on the meter due to the display being damaged.No results were misinterpreted.The product was requested for investigation.The meter and test strips were provided for investigation.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 is ongoing.

Manufacturer Narrative

The meter and test strips were provided for investigation where they were tested.Testing results: (qc range level 1: 30-60 mg/dl; level 2: 261-353 mg/dl).Testing results with the returned meter, retention strips, and retention controls: level 1: 47 mg/dl, 46 mg/dl, 46 mg/dl.Level 2: 317 mg/dl, 317 mg/dl, 314 mg/dl.All results are within acceptable range.No information was provided in the complaint case that would point to a cause for the result discrepancy.Testing with the returned strips was also acceptable.The customer's allegation of questionable results was not observed during testing of returned product, all testing with the returned strips produced acceptable results.This complaint is not verified due to the questionable results allegation not being observed during the investigation of the returned product.Strips batch record review didn't identify any non-conformances issued for this lot related to the customer's allegation.Additionally, retention testing is performed every 3 months an no failures have been observed with this lot.Monitoring for this incident has not exceeded any thresholds or identified any field safety corrective actions.No issues with the meter display were noted during the investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 18631081
• MDR Text Key: 334748227
• Report Number: 1823260-2024-00305
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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: 670234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Date Manufacturer Received: 02/13/2024
• 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: DESCOVY; MEPRON; MYCOSTATIN; NORVASC; TIVICAY; TOPROL-XL; VABRAMYCIN; VALCYTE
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 64 KG