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 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The customer received questionable leukocytes and nitrite results for two nursing home patients tested with combur-10-test strips.The leukocyte and nitrite results from the tests strips were negative for both patients.While testing the patient samples in a hospital laboratory it was confirmed that the patients had acute urinary infections and the leukocyte and nitrite results should have been positive.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The suspected device has been requested for return for further investigation.The investigation is currently ongoing.

Manufacturer Narrative

The customer returned a vial of the test strips.Upon visual inspection of the returned strips, no abnormalities were noticed.The received customer material of lot 32222102 and the retention material of lot 32222100 were both tested visually with a nitrite-dilution-series, a leucocytes-dilution-series, and 0-native-urine.The retention material and customer material performed as expected.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 8357849
• MDR Text Key: 136807088
• Report Number: 1823260-2019-00728
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 04510062171
• Device Lot Number: 32222102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1