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

Catalog Number 05942861001

Device Problems Image Display Error/Artifact (1304); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The reporter's meter and reagents were requested for investigation and replacement product was sent to the reporter.The test strips have not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The reporter's meter and quality control material were returned for investigation, where they were tested using a retention battery and retention test strips.The internal test strip port of the meter was contaminated.Control ranges: level 1: 30-60 mg/dl, level 2: 261-353 mg/dl.Results: level 1: 45 mg/dl, 44 mg/dl, 45 mg/dl, level 2: 306 mg/dl, 300 mg/dl, 307 mg/dl.All returned results are within acceptable range.

Event Description

The initial reporter stated they received questionable glucose results for one newborn patient tested with accu-chek inform ii meter serial number (b)(4).The patient had no symptoms of low glucose.At 6:04 a.M., a sample from the patient was tested using the meter, resulting in a glucose value of 22 mg/dl.At 6:14 a.M., a sample from the patient was tested in the laboratory using an unknown method, resulting in a value of 37 mg/dl.At 8:08 a.M., a sample from the patient was tested using the meter, resulting in a glucose value of 24 mg/dl.At 8:11 a.M., a sample from the patient was tested using the meter, resulting in a glucose value of 28 mg/dl.At 8:28 a.M., a sample from the patient was tested in the laboratory using an unknown method, resulting in a value of 45 mg/dl.The meter's test strip port appeared to be contaminated with quality control material.

Manufacturer Narrative

The test strips were returned for investigation.The test strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.No obvious reagent discoloration were observed.The test strips were tested with glycolyzed blood.All testing with the returned strips produced acceptable results and no strip defects were observed.Per product labeling, "as a matter of good clinical practice, caution is advised in the interpretation of neonate blood glucose values below 50 mg/dl.Please follow the recommendations for follow-up care that have been set by your institution for critical blood glucose values in neonates.Glucose values in neonates suspect for galactosemia should be confirmed by an alternate glucose methodology." 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: 12476690
• MDR Text Key: 273129322
• Report Number: 1823260-2021-02696
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 05942861001
• Device Lot Number: 479244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO MEDICATION