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 Consequences Or Impact To Patient (2199)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation.The retention material of lot 38308901 was visually checked.The retention material showed no missing labels on the cardboard box and no missing label on the test strip vial.

Event Description

The initial reporter stated that the label containing the result interpretation color scale, lot number, and expiration date was missing from one vial of combur 5 test strips.No adverse events were alleged to have occurred as a result of the incident.

Manufacturer Narrative

The customer returned one test strip vial for investigation.It was determined the label on the test strip vial was missing.The packaging line data was reviewed and the line log book showed no abnormalities.The packaging line is equipped with checking devices.The investigation determined a technical failure from the checking system was the root cause.As only a single vial was affected, systematic failure of the checking system is unlikely.There is no risk to patients as the test is visual and the result cannot be read because the color scale is missing from the vial.

• 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: 8734561
• MDR Text Key: 149215926
• Report Number: 1823260-2019-02315
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11896954176
• Device Lot Number: 38308901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1