MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR-10-M 100 STR; URINE TEST STRIPS

Model Number COMBUR-10-M

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).A visual inspection of the test strips showed that the test strip pads were discolored which may indicate mishandling of the test strips.Normal qc was performed on the test strips and a positive nitrite result was also received.Qc was run on a new vial of test strips and the results were ok.The customer doesn't run qc on a regular basis.The customer has installed the new software chip on the meter.The test strips were requested for investigation, however, the customer has discarded the test strips.The retention material of lot 39009700 was measured on an investigation unit cobas u411 with 0-native-urine, a nitrite-dilution-series, and protein-dilution-series and a glucose-dilution-series according to the testing plan.The measurements showed no false positive results and showed no abnormalities.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter questioned results for 1 patient sample tested with combur-10 urine test strips on a urisys 1100 analyzer serial number (b)(4).Based on the data provided, the patient had a false positive nitrite result.The result from the urisys 1100 analyzer was positive.The sample was sent to another laboratory where the nitrite result from an unknown method was "0" (zero).

• Brand Name: COMBUR-10-M 100 STR
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9190131
• MDR Text Key: 217125796
• Report Number: 1823260-2019-03708
• Device Sequence Number: 1
• Product Code: JMT
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: COMBUR-10-M
• Device Catalogue Number: 11379208173
• Device Lot Number: 38908002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1