MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-10-TEST 100 STR.; URINE TEST STRIPS

Catalog Number 04510062171

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's remaining test strips were provided for investigation where both these strips and retention test strips were tested using native urine spiked with an erythrocyte dilution series.The test strip vial returned from the customer was not closed properly.All test strips in the vial showed no abnormalities or signs of discoloration.The results of all test strip measurements fulfilled requirements and no false negative results were observed.This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for one patient urine sample tested with combur 10 test strips.It was asked, but it is not known if an incorrect result was reported outside of the laboratory.The specific date of the event is not known.The reporter initially reported the complaint to the (b)(6) regulatory authorities on (b)(6) 2019.Upon visually reading the erythrocyte/hemoglobin test on the test strip, the test does not indicate signs of hemoglobin or myoglobin in the urine.Microscopic examination of the same sample indicates the presence of erythrocytes at concentrations of 50 erythrocytes/ul.No adverse events were alleged to have occurred with the patient.The reporter's product was requested for investigation.

• Brand Name: COMBUR-10-TEST 100 STR.
• Type of Device: URINE 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: 8707310
• MDR Text Key: 148309745
• Report Number: 1823260-2019-02228
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04510062171
• Device Lot Number: 35703102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Date Manufacturer Received: 05/27/2019
• 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