MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCUTREND PLUS GLUCOSE STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number 11447475187

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Occupation is lay user/patient.The reporter confirmed qc was acceptable.After meter testing, the reporter did not perform a plausibility check.Per product labeling, "plausibility check after glucose measurement: remove the test strip and turn it with the bottom side upwards.Compare the reaction area on the bottom side of the strip with the color field scale on the label of the test strip container.The color of the reaction area must approximately match the color assigned to your measurement result.If there is a great deviation, perform a meter function check." the reporter's test strips and meter were requested for return.The product has not been received at this time and is not expected to be returned.If the product is returned in the future, a follow up report will be submitted.

Event Description

The initial reporter complained of discrepant glucose results with an accutrend plus meter serial number (b)(4) compared to two accu-chek aviva meters.The reporter performed side by side meter comparison testing with the accutrend plus meter and two accu-chek aviva meters.During comparison testing, the reporters "blood was applied on one strip first, then on the other strip straight after." the reporter confirmed the test strips used for comparison testing were visually ok.The reporter's glucose result with the accutrend plus meter was 2.8 mmol/l.The reporter's glucose result with an accu-chek aviva was 5.2 mmol/l.The reporter's glucose result with another accu-chek aviva was "5.2 or 5.3 mmol/l.".

Manufacturer Narrative

Customer samples and retention samples glucose lot 37996005 were measured with controls gkl 60 lot 346092-99 /gkl 180 lot 346093-99 and 2 edta blood on customer device and reference devices compared to laboratory method.Results: the mean of the measurements with returned samples glucose lot 37996005 test strips and 1st edta blood sample is as follows: - customer instrument: 82.9mg/dl - retention instrument: 88 mg/dl the mean of the measurements with returned samples glucose lot 37996005 test strips and 2nd edta blood sample is as follows: - customer instrument: 140.5 mg/dl - retention instrument: 136 mg/dl the mean of the measurements with retention samples glucose lot 37996005 test strips and 1st edta blood sample is as follows: - customer instrument: 85.9 mg/dl - retention instrument: 84.7 mg/dl the mean of the measurements with retention samples glucose lot 37996005 test strips and 2nd edta blood sample is as follows: - customer instrument: 136.3 mg/dl - retention instrument: 135.7 mg/dl the mean of the measurements with control solution gkl60 with retention test strips is as follows: - customer instrument: 4.2 mmol/l - retention instrument: 78.7 mg/dl the mean of the measurements with control solution gkl180 with retention test strips is as follows: - customer instrument: 10.7 mmmol/l - retention instrument: 196 mg/d ranges glu control solutions: range gkl60: 3.2 - 5.4 mmol/l 58-98 mg/dl range gkl180: 9.5 - 12.9 mmol/l 172 ¿ 232 mmol/l the mean of the measurements with laboratory method (cobas) is as follows: - blood 1: 81.7 mg/dl - blood 2: 133.4 mg/dl all measurements with retention test strips on the reference instrument and the customer instrument are within the control ranges.No product problem was found.Medwatch fields d9 and h3 were updated.

• Brand Name: ACCUTREND PLUS GLUCOSE STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10696224
• MDR Text Key: 214799687
• Report Number: 1823260-2020-02573
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K051376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

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: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 11447475187
• Device Lot Number: 37996005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1