MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-9-TEST 50STR.; URINE TEST STRIPS

Catalog Number 04510038191

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer complained of false positive nitrite results with the combur-9-test strips from multiple containers over an unspecified period of time.Specific data or repeat testing results were not provided.There was no allegation of an adverse event.The customer suspected the lid had been left off of the strip container and the they correctly replaced container lid.The suspect product was requested to be returned for investigation.

Manufacturer Narrative

Customer material was requested for investigation, but was not provided.The investigation was unable to find a definitive root cause.

Manufacturer Narrative

The customer did not perform quality control on the test strips.The investigation determined that the nitrite test pad is one of the first pads on the test strip to become discolored when exposed to moisture and air, which can lead to incorrect results.

• Brand Name: COMBUR-9-TEST 50STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7602202
• MDR Text Key: 111851800
• Report Number: 1823260-2018-01912
• 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: 08/14/2018

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: 04510038191
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 05/29/2018
• Supplement Dates FDA Received: 07/26/2018; 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1