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 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Daily quality controls were acceptable on both meters.The customer ran a correlation study and linearity studies on meter (b)(4) and the results were acceptable.Five strips of lot 479336 (vial (b)(4) roll (b)(4)) were received for investigation.The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.There was no apparent reagent discoloration.More than 12 strips of lot 479336 (vial (b)(4) roll (b)(4)) were received for investigation.The strip vial, desiccant, and vial cap were inspected and were acceptable in appearance.There was no apparent reagent discoloration.All testing with the returned strips produced acceptable results and no strip defects were observed.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.

Event Description

There was an allegation of questionable glucose results from accu-chek inform ii meters.At 7:05 am, the result from meter (b)(4) was 53 mg/dl from pic line.The staff thought his clinical presentation did not match this low blood sugar.At 7:08 am, the result from meter (b)(4) was 17 mg/dl from a fingerstick.At 7:10 am, the result from meter (b)(4) was 47 mg/dl from a fingerstick.At 7:11 am, the result from meter (b)(4) was 49 mg/dl from a fingerstick.At 7:13 am, the result from meter (b)(4) was 220 mg/dl.At 7:15 am, the result from meter (b)(4) was 188 mg/dl.At 7:25 am, the result from the laboratory was 38 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: 12698991
• MDR Text Key: 278561141
• Report Number: 1823260-2021-03126
• 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: 10/26/2021

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: 04/30/2022
• Device Catalogue Number: 05942861001
• Device Lot Number: 479336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/26/2021
• 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: 64 YR
• Patient Weight: 57