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 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

The meter and test strips were requested for investigation.The product has not been received at this time.

Event Description

There was a complaint of discrepant glucose results for one patient tested with an accu-chek inform ii meter serial number (b)(4) compared to itself and a laboratory test with an unknown reagent.The result from the meter at 7:20 am was 44 mg/dl.The result from the meter at 7:21 am was 80 mg/dl.The result from the laboratory at 7:30 am was 148 mg/dl.

Manufacturer Narrative

Fields d9 and h3 updated.The test strips were provided for investigation where they were tested using a reference meter with glycolyzed blood samples.All testing with the returned strips produced acceptable results and no strip defects were observed.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 did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 12466616
• MDR Text Key: 271255226
• Report Number: 1823260-2021-02690
• Device Sequence Number: 1
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (y/n): N
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 05942861001
• Device Lot Number: 479692
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ASPIRIN; BISACODYL; DEXTROSE 50 ML; DEXTROSE NACL (1000 ML AT 100 ML/HOUR); DULOXETINE HCL; GABAPENTIN; HYDROCHLOROTHIAZIDE; LACTULOSE; LIPITOR; LOVENOX; MELATONIN; METHADONE HCL; MILK OF MAGNESIA; PROCHLORPERAZINE; QUINAPRIL HCL; THIAMINE; VITAMIN B6; ACETAMINOPHEN; ASPIRIN; BISACODYL; DEXTROSE 50 ML; DEXTROSE NACL (1000 ML AT 100 ML/HOUR); DULOXETINE HCL; GABAPENTIN; HYDROCHLOROTHIAZIDE; LACTULOSE; LIPITOR; LOVENOX; MELATONIN; METHADONE HCL; MILK OF MAGNESIA; PROCHLORPERAZINE; QUINAPRIL HCL; THIAMINE; VITAMIN B6
• Patient Age: 73 YR
• Patient Weight: 65