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

Catalog Number 11447475160

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer complained of questionable glucose results with the accutrend plus meter serial number (b)(4) compared to multiple patient meters.Of the data provided, there was an erroneous glucose result for one patient.The glucose result was 19 mmol/l with a freestyle libre meter.The glucose result was 4.2 mmol/l on the accutrend plus meter 5 minutes later.There was no allegation of an adverse event.The qc was in range on the day of the event.The customer has been performing qc daily since the event and the qc results have been within the normal range.The customer's product was requested for investigation.

Manufacturer Narrative

The customer's meter was returned for investigation.The test strips were not available.Reference glucose samples of lot 238243 and control solutions were measured on the customer meter and reference meters.The results were within control ranges.The investigation was unable to find a definitive root cause.

• 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: 7410433
• MDR Text Key: 105270472
• Report Number: 1823260-2018-01092
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 11447475160
• Device Lot Number: 137690-8
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MEDICATION; IRON; OLANZAPINE; ZISPIN