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 08/07/2021

Event Type  malfunction  

Manufacturer Narrative

Qc was run on each meter on the days in question and both levels passed.The test strips were requested for investigation, however, there are no strips to return as the vials have all been used up.No product is expected for return.If any product is returned in the future, a follow up report will be submitted.On a regular basis, inform test strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.

Event Description

The initial reporter complained of questionable glucose results for 1 patient tested with 3 accu-chek inform ii meters: (b)(4) (meter (b)(6)).(b)(4) (meter (b)(6)).(b)(4) (meter (b)(6)).On (b)(6) 2021 the patient was only tested with meter (b)(6): at 6:14 a.M.The result was 48 mg/dl.At 6:14 a.M.The result was 86 mg/dl.At 6:45 a.M.The result was 43 mg/dl.At 8:58 a.M.The result was 46 mg/dl.On (b)(6) 2021 at 4:07 p.M.The result from meter (b)(6) was 176 mg/dl.At 7:57 p.M.The result from meter (b)(6) was 175 mg/dl.On (b)(6) 2021 at 12:04 a.M.The result from meter (b)(6) was 169 mg/dl.On (b)(6) 2021 at 5:14 a.M.The patient had a glucose result from the laboratory of 95 mg/dl.On (b)(6) 2021 at 6:03 a.M.The result from meter (b)(6) was 38 mg/dl.At 6:12 a.M.The result from meter (b)(6) was 47 mg/dl.At 6:30 a.M.The patient had a glucose result from the laboratory of 319 mg/dl.At 6:43 a.M.The result from meter (b)(6) was 35 mg/dl.At 6:54 a.M.The result from meter (b)(6) was 313 mg/dl.

• 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: 12453861
• MDR Text Key: 272787029
• Report Number: 1823260-2021-02660
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 05942861001
• Device Lot Number: 479432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/10/2021
• 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: 71 YR