MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 6-TEST 50 STR.; URINE TEST STRIPS

Catalog Number 11896962257

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable false positive urine nitrite results for an unknown number of patient samples.The customer stated the test pads were discolored and the pad looked pink before testing.It was unknown if any questionable result was reported outside of the laboratory.

Manufacturer Narrative

The customer¿s products have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.The retention material of lot 39008700 was measured by visual reading with a nitrite dilution series and native urine.The retention material fulfilled the requirements and no false positive results observed.

• Brand Name: COMBUR 6-TEST 50 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9806639
• MDR Text Key: 220567141
• Report Number: 1823260-2020-00678
• 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: 06/29/2020

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: 08/30/2020
• Device Catalogue Number: 11896962257
• Device Lot Number: 39008702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1