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

Catalog Number 04510046040

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s products have been requested for return.The retention material of lot 40392900 was visually checked.The retention material showed no abnormalities and no signs of discolorations.The retention material fulfilled the requirements.The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable result false positive nitrite results for an unknown number of patients.The customer had noticed almost half of the test strips in the vial had a discolored nitrite pad that was light pink before the test strip was used.They believed this led to the false positive nitrite results.The questionable results were reported outside of the laboratory.

Manufacturer Narrative

One vial of combur-9-test 100 str.Of lot# 40392902 containing 124 of 100 test strips was received for investigation.79 of the test strips were discolored and 45 test strips showed no abnormalities as there were more strips in the vial than when manufactured and the customer mixed up several strip lots together in one vial, the issue was determined to be a handling error by the customer.Product labeling for the product states " tightly re-cap the container immediately after removing a test strip.This will avoid discoloration of the strips.".

• 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: 10115764
• MDR Text Key: 203687277
• Report Number: 1823260-2020-01359
• 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: 08/11/2020

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 Catalogue Number: 04510046040
• Device Lot Number: 40392902
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1