MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 5-TEST HC 10 STR.; URINE TEST STRIPS

Catalog Number 11896954176

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

The test strips were requested for investigation.The retention material of lot 373776 was tested with a nitrite-, a protein-, a glucose-, an erythrocytes-, a leucocytes-dilution-series and 0-native-urine.The retention material showed no false negative results or abnormalities.The material meets the requirements.

Event Description

The initial reporter complained of false negative results for 1 patient tested with combur 5 urine test strips.The patient was tested in surgery by an unknown method with positive results for nitrite, leucocytes and erythrocytes.The patient was tested in the pharmacy with combur 5 test strips and received negative results for nitrite, leucocytes and erythrocytes.No other specifics related to the event or results could be provided by the reporter.There was no allegation that an adverse event occurred.The patient is fine.

Manufacturer Narrative

The customer returned one vial containing 3 strips which showed no visual abnormalities.The customer returned material was tested an erythrocytes-dilution-series, a leucocytes-dilution-series and 0-native-urine.The investigation found no false-negative results, fulfilling the requirements.Medwatch sections concomitant medical products and device evaluated by mfr have been updated.

• Brand Name: COMBUR 5-TEST HC 10 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8727878
• MDR Text Key: 149092919
• Report Number: 1823260-2019-02293
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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: 11896954176
• Device Lot Number: 37377601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1