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 10/25/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable glucose results from accu-chek inform ii meters.At 7:41 am, the result from meter serial number (b)(4) was 229 mg/dl.At 8:28 am, the laboratory result was 65 mg/dl.At 9:14 am, the result from meter serial number (b)(4) was 297 mg/dl.At 10:06 am, the result from meter serial number (b)(4) was 422 mg/dl.At 10:13 am, the result from meter serial number (b)(4) was 163 mg/dl.At 11:00 am, the laboratory result was 212 mg/dl.The patient was not treated based on the result from either meter, as the operators did not believe the results from the meters.The reporter did not know what treatment if any was provided based on the laboratory results.

Manufacturer Narrative

Quality controls were tested on both meters and passed.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

Greater than 12 strips were returned for lot 670205.The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.No obvious reagent discoloration.The strips were tested with a retention meter and quality controls.Control ranges: level 1: 30-60 mg/dl level 2: 261-353 mg/dl results: level 1: 46, 45, and 45 mg/dl level 2: 274, 289, and 298 mg/dl all returned results are within the acceptable range.No information was provided that would point to a cause for the discrepancy.Medwatch fields d9 and h3 were updated.

• 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: 15789466
• MDR Text Key: 303925373
• Report Number: 1823260-2022-03599
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 05942861001
• Device Lot Number: 670205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• 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 Age: 35 YR
• Patient Sex: Female