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 11/19/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable glucose results for one patient tested with accu-chek inform ii meter serial number (b)(4).At 8:06 a.M., a sample from the patient tested with the meter resulted in a glucose value of 308 mg/dl.This result was questioned, so repeat testing was performed on the patient.At 8:18 a.M., a sample from the patient tested with the meter resulted in a glucose value of 154 mg/dl.At 8:19 a.M., a sample from the patient tested with the meter resulted in a glucose value of 275 mg/dl.The repeat tests were also questioned.Controls run in the morning prior to patient testing passed.

Manufacturer Narrative

The customer's meter and test strips were requested for investigation and replacement products were sent to the customer.The customer's meter was returned for investigation where it was tested using a retention battery, retention test strips, and retention controls.Control ranges: level 1: 30-60 mg/dl, level 2: 261-353 mg/dl.Results: level 1: 43 mg/dl, 41 mg/dl, 43 mg/dl, level 2: 290 mg/dl, 286 mg/dl, 297 mg/dl.All returned results are within the acceptable range.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.

• 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: 15925433
• MDR Text Key: 308075077
• Report Number: 1823260-2022-03896
• Device Sequence Number: 1
• Product Code: LFR
• UDI-Device Identifier: 10365702428109
• 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
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• 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