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

Catalog Number 05942861018

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

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable glucose results for two patients tested with the accuchek inform ii meter.Patient 1: the initial result from the meter was "lo".The result from another accuchek inform ii meter was 5.9 mmol/l.The result from the radiometer blood gas meter was 5.9 mmol/l.Patient 2: the initial result from the meter was "lo".The result from another accuchek inform ii meter was 11 mmol/l.The result from the radiometer blood gas meter was 11 mmol/l.The reference range for "lo" was set at 2.5 mmol/l.The reporter stated that the tests were all run one straight after the other and it was only a matter of a few minutes between tests.

Manufacturer Narrative

The serial number of the accuchek inform ii meter is (b)(6).The customer performed qc; the results were acceptable.The reporter's test strips were requested for investigation and have not been received at this time.If the product is returned in the future, a follow-up report will be submitted.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.

Manufacturer Narrative

Medwatch field d9 was updated.The test strips were received for investigation.The investigation inspected the strip vial, desiccant, and vial cap; they were acceptable in appearance and there was no obvious reagent discoloration.The investigation verified the information in the vial and the vial's integrity; the investigation determined there is evidence to support that the returned product was appropriately sealed.The test strips were tested using glycolyzed blood; the test results were acceptable and no test strip defects were observed.The investigation did not identify a product problem.

• 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: 18118104
• MDR Text Key: 327888694
• Report Number: 1823260-2023-03580
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05942861018
• Device Lot Number: 670447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1