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 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

Quality controls were run on both meters and were acceptable.The meter and strips have been requested for return.All testing with the returned strips produced acceptable results and no strip defects were observed.Testing summary: 12 strips returned from strip lot# 480034 (vial 00754).The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.No obvious reagent discoloration.12 strips returned from lot# 480034 (vial 00392).The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.No obvious reagent discoloration.Three strips returned from strip lot# 480034 (vial 01358).The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.No obvious reagent discoloration.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.The investigation is ongoing.

Event Description

There was an allegation of questionable glucose results from two accu-chek inform ii meters.At 17:58 using meter serial number (b)(4), the result was 500 mg/dl.At 17:59 using meter serial number (b)(4), the result was 105 mg/dl.At 18:07 using meter serial number (b)(4), the result was 243 mg/dl.

Manufacturer Narrative

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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12984613
• MDR Text Key: 289974758
• Report Number: 1823260-2021-03673
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 05942861001
• Device Lot Number: 480034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 77 KG