MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 10-TEST UX 100T; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number 11544373191

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported they received wrong results with combur 10 test strips lot 11609704 on several instruments for qc material and patient samples.Information was provided for urisys 1100 serial number (b)(4).Information was provided that there were "big differences at glucose, leu, ket, ubg".No specific patient data could be provided.There was no mistreatment of the patient as the doctor who complained had noticed the wrong results before treating the patient.The instrument was checked and was ok.It was tested with other combur strips.The suspect strips were requested to be returned for further investigation.

Manufacturer Narrative

One vial of lot 11609704 was received from the customer for investigation.There were no noticeable defects.The customer material and the retention material of lot 11609700 were measured with bio-rad urinalysis control level 2 (lot #65862) on a urisys 1100 device.No false results were observed and the performance of the test strip fulfilled the requirements.No other complaints were received for this lot.The effect of incorrect test strip positioning under the tray clip was investigated.If the test strip is not correctly pushed under the tray clip, incorrect lower results were observed.This type of issue may be caused by mishandling or a dirty tray.

• Brand Name: COMBUR 10-TEST UX 100T
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• 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: 6016754
• MDR Text Key: 57057364
• Report Number: 1823260-2016-01546
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11544373191
• Device Lot Number: 11609704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1