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 10/04/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable glucose results from accu-chek inform ii meter serial number (b)(4).At 10:56 am, the result was 401 mg/dl.At 10:59 am, the result was 276 mg/dl.At 9:04 pm, the result was 401 mg/dl.At 9:13 pm, the result was 235 mg/dl.No treatment was provided to the patient based on either questionable result of 401 mg/dl as the nurse stated the patient's baseline glucose results average in the 200's mg/dl and she did not believe the results of 401 mg/dl to be accurate.

Manufacturer Narrative

Qc was performed on (b)(6) 2022 and passed for both levels.The meter and strips have been requested for return.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 investigation is ongoing.

Manufacturer Narrative

No product was returned.No further investigation could be performed.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15698500
• MDR Text Key: 303245198
• Report Number: 1823260-2022-03432
• 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
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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: 670103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• 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
• Patient Sex: Male