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

Catalog Number 05942861170

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant glucose results for one patient tested with an accu-chek inform ii meter.At 19:46 on (b)(6) 2023, a sample from the patient was tested using the meter, resulting in a glucose value of 25 mmol/l.At 19:48 on (b)(6) 2023, a sample from the patient was tested using the meter, resulting in a glucose value of 9.2 mmol/l.At an unknown time on (b)(6) 2023, a sample from the patient was tested with the meter, resulting in a glucose value of 18.6 mmol/l.Minutes after the first measurement on (b)(6) 2023, a sample from the patient was tested with the meter, resulting in a glucose value of 7.5 mmol/l.

Manufacturer Narrative

The meter serial number is (b)(6).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.

• 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: 18094028
• MDR Text Key: 327655050
• Report Number: 1823260-2023-03556
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): Y
• Reporter Country Code: NO
• 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
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05942861170
• Device Lot Number: 670528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• 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