MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 10 UX 100; URINE TEST STRIPS

Model Number U1100

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The analyzer has been used since this event and all results have been accurate.Qc had passed.

Event Description

The initial reporter complained of discrepant results for 1 patient tested for leukocytes on a urisys 1100 analyzer.The result from the instrument was negative.When they checked visually the result was positive (500 leukocytes).The combur 10 test strip lot number was 38055304 with an expiration date of 31-mar-2020.

Manufacturer Narrative

The customer did not return any product.The suspect medical device has been updated.Applicable fields of sections d and g were updated.The (b)(6) analyzer serial number was (b)(6).Section h9 was updated.During internal testing, roche determined the limits of detection (lod) for protein, nitrite, leukocytes, and erythrocytes on the (b)(6) urine analyzer with chemstrip® 5 ob, chemstrip 7, chemstrip 10 md, and chemstrip 10 ua test strips were higher than what is listed in their respective test strip method sheets.This can lead to false negative results on the (b)(6) urine analyzer for the four affected parameters.Roche has provided customers with the following instructions and work arounds: chemstrip 5 ob and chemstrip 7 test strips should only be read visually.They can no longer be read on the (b)(6)urine analyzer.Chemstrip 10 md or chemstrip 10 ua test strips can be used with the (b)(6) urine analyzer; however, a negative result for any one of the four affected parameters (i.E., protein, nitrite, leukocytes, and erythrocytes) on the (b)(6) urine analyzer must be repeated with a new test strip that is read visually.

• Brand Name: COMBUR 10 UX 100
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9466460
• MDR Text Key: 219351126
• Report Number: 1823260-2019-04412
• 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: 07/29/2020

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: 03/31/2020
• Device Model Number: U1100
• Device Catalogue Number: 03617548001
• Device Lot Number: 38055304
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES81177
• Patient Sequence Number: 1