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 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s products have been requested for return.The retention material of lot 39009000 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 false positive nitrite results for an unspecified number of patient samples tested with combur-9-test strips.The customer stated that they had the same issue with a different strip box beforehand.The lot number and expiration date of the other strip lot was not provided.The customer was in a surgery when the false positive results were observed.The questionable results were reported outside of the laboratory.

Manufacturer Narrative

D10 and h3 were updated.The customer's test strips were returned for investigation.The test strips showed signs of discoloration.The investigation is ongoing.

Manufacturer Narrative

Additional tests for seal tightness were performed on the packaging line.The tests showed the following results: the customer material failed the test for tightness.After changing the desiccant stopper, the customer material passed the test.The desiccant stoppers from retention material have a slightly higher diameter than the customer material stoppers.No abnormalities of the used desiccant stopper vials were observed during quality control process, while checking the production documentation, packaging line documentation and technical logbooks.The possibility of the issue occurring outside of roche during the transport or logistic process could not be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 10275345
• MDR Text Key: 200422047
• Report Number: 1823260-2020-01695
• 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,Followup
• Report Date: 11/11/2020

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 04510046040
• Device Lot Number: 39009003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 06/17/2020; 06/17/2020
• Supplement Dates FDA Received: 08/10/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1