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

Catalog Number 11447475160

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

The accutrend glucose test strip lot 34902901 which was used for the alleged measurements on the date of the event in 2019, had already expired at the time the complaint was received.Therefore, the test strips were not requested for return.The customer's meter was requested for return.Product labeling states: "this system has not been proven for use with neonates." the investigation is ongoing.

Event Description

The initial reporter received questionable glucose results from an accutrend plus meter serial number (b)(4).The initial result was approximately 180 mg/dl.The exact value was not provided.The repeated result was 83 mg/dl.The repeated result was taken within 15 minutes of the initial result.The repeated result was believed to be correct.Both results were taken at the patient's pediatrician's office.

Manufacturer Narrative

Sections d9 and h3 updated.The customer's meter was returned for investigation.The investigation found the device to be contaminated with human material (blood).The investigator attempted to clean the device, but found that the device is broken and no measurements are possible.The customer's glucose strips lot 349029-01 have expired in may 2020.Retention samples glucose lot 349029-01 and reference lot glucose 481926-80 were measured with controls gkl 60 lot 346092-99/gkl 180 lot 346093-99 and 2 edta blood on reference devices compared to laboratory method.Results: all results were within the control range.No significant differences to the laboratory method.The customer's device is broken.There were no abnormalities in the test strips.Based on the measurements, no product issue was identified.

• Brand Name: ACCUTREND TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10958169
• MDR Text Key: 243691572
• Report Number: 1823260-2020-03108
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K952875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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: 05/31/2020
• Device Catalogue Number: 11447475160
• Device Lot Number: 34902901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Weight: 3