MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 10 TESTÿ® M; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Catalog Number 11379208191

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated on (b)(6) 2020 that they have received discrepant high nitrite results for an unspecified number of patient samples tested with combur 10 m test strips on a cobas u 411 analyzer.The reporter states that approximately every 10th patient sample will have a high nitrite result when tested, but when checking the sample sediment microscopically, no bacteria are visible.Bacterial cultures for these samples are negative.The issue occurred for "about two weeks" after starting use of test strip lot number 42219803.The specific date of the event is not known.The unused test strip nitrite test pads are white.After the affected samples are tested, the nitrite test pads appear to be pink visually.The u 411 analyzer serial number was requested, but not provided.

Manufacturer Narrative

The reporter sent a vial of a different test strip lot number (lot 42220101) since they accidentally mixed up the vials and had no material available of the complained lot.Only retention material of lot 42219800 was measured for investigation.The retention material of lot 42219800 was measured on a retention cobas u411 and was tested visually with native urine and a nitrite dilution series.The measurements fulfilled requirements.

• Brand Name: COMBUR 10 TESTÿ® M
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9633479
• MDR Text Key: 214403556
• Report Number: 1823260-2020-00205
• 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: 05/12/2020

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: 11/30/2020
• Device Catalogue Number: 11379208191
• Device Lot Number: 42219803
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1