MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 5-TEST HC 10 STR.; URINE TEST STRIPS

Model Number COMBUR 5

Device Problem Missing Information (4053)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.The follow up/corrective actions were: retention materials were checked and fulfilled requirements.The packaging department did not observe any abnormalities.In process control procedures were also completed without any abnormalities.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.The initial reporter stated that they received a combur 5-test strip vial without a label which includes lot number, expiration date, and color interpretation chart.The outer packaging was labeled, but this label includes only the lot number and expiration date.No patients were involved.The patients' ages: na.The patients' weights : na.The patients' genders were: na.The patients' races were: na.The patients' ethnicities were: na.

• Brand Name: COMBUR 5-TEST HC 10 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8544213
• MDR Text Key: 142922141
• Report Number: 1823260-2019-90098
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 04015630004614
• UDI-Public: 4015630004614
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: COMBUR 5
• Device Lot Number: 36253201
• Type of Device Usage: N
• Patient Sequence Number: 1