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

Catalog Number 05942861003

Device Problems Defective Device (2588); Non Reproducible Results (4029)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

The meter serial numbers were (b)(6).As part of troubleshooting, the staff tested themselves on one of the two devices and received a result of 300 mg/dl.The result from another inform meter in the neonatology department was 200 mg/dl.The quality control results from both meters were acceptable.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 meter and strips have been requested for return.However, the test strips were no longer available.

Event Description

There was an allegation of questionable low glucose results from two accu-chek inform ii meters.The customer alleged the results from the meter for multiple patients were "lo" (less than 10 mg/dl).The results with a bga device or from another inform ii meter in the neonatology department were within the normal range.No specific data was provided.

Manufacturer Narrative

The reporter's meters were received for investigation and were tested with retention test strips and quality control materials.Control ranges: level 1: 30-60 mg/dl.Level 2: 261-353 mg/dl.Meter serial number (b)(6).Results: level 1: 43, 42, 43 mg/dl.Level 2: 300, 302, 295 mg/dl.Meter serial number (b)(6).Results: level 1: 43, 44, 42 mg/dl.Level 2: 304, 304, 298 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 discrepancy.

Manufacturer Narrative

As no product was received, further investigation was not possible.The investigation did not identify a product problem.

• Brand Name: ACCU-CHEK INFORM II
• 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: 18850655
• MDR Text Key: 337076349
• Report Number: 1823260-2024-00678
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05942861003
• Device Lot Number: 670685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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