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 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

The customer's materials were returned.One vial of strip lot 38308901 "combur 5-test hc 10 str.", containing 10 of 10 test strips was returned.Investigation: the customer material of lot 38308901 and the retention material of lot 38308901 were both visually checked.Results: the retention material showed no missing labels on the cardboard-box and no missing label on the test strip vial.The label on the test strip vial of the customer material is missing.The retention material visual inspection was acceptable.

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.There was no allegation of an adverse event.

Manufacturer Narrative

The manufacturing documents and the packaging logbook showed no abnormalities.Evaluation method, result, and conclusion codes have been updated.

Manufacturer Narrative

Medwatch field b1 was updated.

• 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: 8735842
• MDR Text Key: 149380974
• Report Number: 1823260-2019-02327
• 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,Followup
• Report Date: 02/25/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 11896954176
• Device Lot Number: 38308901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/07/2019; 06/07/2019
• Supplement Dates FDA Received: 07/22/2019; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1