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

Catalog Number 11896954176

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained that the label was missing from the box and the vial of the combur 5 urine test strips.There was no allegation of an adverse event.No test strips were used.The suspect product was requested to be returned for investigation.The retention material of lot 32221301 was visually checked and the boxes had the correct label.

Manufacturer Narrative

One test strip vial of lot 32221301 was received from the customer and the missing label was confirmed.Retention material of lot 32221301 was visually checked and the label was found to be missing on several vials.The label was confirmed to be present on the boxes.A specific root cause could not be determined, it could not be excluded that an unlabeled vial passed through the packaging process undetected.

• 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: 8023143
• MDR Text Key: 126542443
• Report Number: 1823260-2018-03942
• 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: 02/18/2019

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: 10/31/2019
• Device Catalogue Number: 11896954176
• Device Lot Number: 32221301
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1