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

Catalog Number 05942861001

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

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

The customer returned test strips from lot 480035 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.

Event Description

There was an allegation of charging/power issues and questionable glucose results from two accu-chek inform ii meters.At 13:40, the result from meter serial number (b)(4) was 41 mg/dl.As the patient had previous results near 70 to 100 mg/dl.The customer repeated testing on a second meter.At 13:41, the result from meter serial number (b)(4) was 100 mg/dl.

Manufacturer Narrative

The customer's test strips were returned for investigation.The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.No obvious reagent discoloration.Returned test strips were tested with glycolyzed blood.All testing with the returned strips produced acceptable results and no strip defects were observed.

Manufacturer Narrative

The returned meter was tested with retention strips and retention controls.Control ranges: level 1: 30-60 mg/dl level 2: 261-353 mg/dl results: level 1: 45, 44, and 45 mg/dl level 2: 302, 307, and 308 mg/dl all returned results are within acceptable range.The log file did not indicate any hardware or software issues that would lead to a measurement discrepancy.The meter was disassembled for further investigation.No damage or contamination observed.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13029427
• MDR Text Key: 290297521
• Report Number: 1823260-2021-03769
• Device Sequence Number: 1
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (y/n): N
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 05942861001
• Device Lot Number: 480035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• 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