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

Catalog Number 11544373049

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The instrument software version is (b)(6).The instrument was calibrated on (b)(6) 2019.The meter and test strips were requested for investigation.

Event Description

The initial reporter complained of false positive nitrite results for an unspecified number of patients using combur 10 urine strips with a urisys 1100 analyzer.The instrument gives a positive nitrite result, but the visual result is negative.Negative controls also produce a positive result.The customer states some of the combur 10 urine test strips "look strange." the customer states some of the strips are visually "bolder" than normal and some of the test strips are not straight.The customer is also having trouble inserting the test strip into the instrument.The urisys 1100 analyzer serial number is (b)(4).

Manufacturer Narrative

The customer returned the instrument and test strips.The instrument was returned with no test strip tray.The device was clean and showed no damage.The test strips showed no abnormalities.The retention material of lot 40758900 was measured on an iu cobas u411 / urisys 1800 with 0-native-urine and a nitrite-dilution-series.The customer material of lot 40758902 was measured on an iu cobas u411 / urisys 1800 with 0-native-urine and a nitrite-dilution-series.The retention material and the customer material were checked by visual reading with 0-native-urine and a nitrite-dilution-series.Additionally, the customer urisys 1100 analyzer ux09638693 was measured with another strip lot 43065200 with 0-native urine.The retention material and the customer material showed no false positive results and fulfill the requirements.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 9482674
• MDR Text Key: 219212691
• Report Number: 1823260-2019-04453
• 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: 04/16/2020

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 Catalogue Number: 11544373049
• Device Lot Number: 40758902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1