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 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation.The retention material of lot 41567701 was visually checked.The retention material shows no abnormalities.One vial of test strips was returned for investigation.The label on the test strip vial is missing.Technical documentation, logbook, and production documentation were checked and there were no entries which could imply the root cause of this error pattern.An unknown technical failure occurring during manufacturing is the root cause of the defective vial.

Event Description

The initial reporter stated they received a vial of combur 5 test strips which did not have the complete label affixed to the vial.The vial label was completely missing, so the color comparison scale used for interpreting test results was missing.The outer packaging of the vial was labeled with information including the lot and expiration date.The test strips were not used.The reporter also had no other test strips of the same lot number nearby.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9370087
• MDR Text Key: 218521295
• Report Number: 1823260-2019-04175
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 11896954176
• Device Lot Number: 415677-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1