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

Event Description

The initial reporter stated that they received a discrepant glucose result for one patient tested with accu-chek inform ii meter with serial number (b)(4).The result was compared to a second accu-chek inform ii meter with an unknown serial number.The result from the first meter at 8:54 pm was <10 mg/dl.The result from the second meter at 9:00 pm was 88 mg/dl.The reporter stated that this result was closer to the result from the patient's continuous blood glucose monitor.The reporter could not recall the exact result from the monitor.The patient was not treated based on the results.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.A routine retention testing process has been implemented.Valid retention results are available for all lots in the event a strip lot is alleged in a complaint.All retention data is reviewed on a monthly basis once testing is complete.If a failing result is observed during testing, appropriate actions will be taken.

• 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: 12488822
• MDR Text Key: 271958560
• Report Number: 1823260-2021-02722
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACTRIM; FLONASE; GABAPENTIN; LEVEMIR; LEVOTHYROXINE; LIPITOR; LOVENOX; NOVOLOG; OXYCODONE; PROTONIX; BACTRIM; FLONASE; GABAPENTIN; LEVEMIR; LEVOTHYROXINE; LIPITOR; LOVENOX; NOVOLOG; OXYCODONE; PROTONIX
• Patient Age: 63 YR
• Patient Weight: 64