MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-9-TEST; URINE TEST STRIPS

Catalog Number 04510038191

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s products have been requested for return.This event occurred in (b)(6).

Event Description

The initial reporter received a questionable false positive nitrite result for one patient sample.The positive result did not fit the patient status.With another package of the same lot, the nitrite result was negative.The questionable result was reported outside of the laboratory.

Manufacturer Narrative

Medwatch field d4 - catalog no was updated.One vial of combur-9-test strips lot 38054702, containing 45 of 50 test strips was received for investigation.The received customer material and the retention material of lot 38054700 were both visually checked.The customer material shows discolorations on following test pads: nitrite, protein, ketone, bilirubin.The retention material shows no abnormalities.The customer material was checked for tightness which passed.

• Brand Name: COMBUR-9-TEST
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9474795
• MDR Text Key: 209359299
• Report Number: 1823260-2019-04439
• 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: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 04510038191
• Device Lot Number: 38054702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1