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

Catalog Number 05942861001

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Quality control tests were performed and passed for both levels.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 test strips were requested for further investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable glucose results from an accu-chek inform ii meter.A neonate patient was tested via a heel-stick test with meter uu14477587 at 6:24 am and the result was 38 mg/dl.The operator thought that the result was too low for the patient.Two minutes later at 6:26 am, the patient was retested via heel-stick test with meter uu14477610 and the result was 55 mg/dl.This result was believed correct.

Manufacturer Narrative

No customer product was received.Therefore, further investigation was not possible.

Manufacturer Narrative

The customer's meter was received for investigation and was tested with retention test strips and quality control materials.Control ranges: level 1: 30-60 mg/dl.Level 2: 261-353 mg/dl.Results: level 1: 43, 44, and 43 mg/dl.Level 2: 297, 297, and 296 mg/dl.All returned results were within acceptable range.The meter 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 was observed.No information was provided that would point to a cause for the result discrepancy.

• 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: 18310696
• MDR Text Key: 330282497
• Report Number: 1823260-2023-03953
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: 670858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• 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
• Patient Sex: Male
• Patient Weight: 2 KG