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

Catalog Number 11896954176

Device Problem Missing Information (4053)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated the label on a combur 5-test strip vial was missing.The label containing the visual reading color scale was neither on the vial or loose within the box.No adverse events were alleged to have occurred.The customer's product was requested for investigation.One box containing a test strip vial was received for investigation.The box packaging is labeled and showed no abnormalities.The label on the test strip vial was missing.The vial showed some slight scratches.The stock of retention samples were visually checked and the boxes show the correct placed label.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• 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 0457
• MDR Report Key: 8068772
• MDR Text Key: 129164197
• Report Number: 1823260-2018-04263
• 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: 02/26/2019

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: 01/31/2020
• Device Catalogue Number: 11896954176
• Device Lot Number: 34760801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1