MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PT TEST; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625315003

Device Problems Inadequate or Insufficient Training (1643); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  malfunction  

Event Description

The customer state the information on the label of their test strip box does not match the information on the strip vial label.Customer stated the box label states the test strips are lot 56099311 with expiration date 31-mar-2023.The customer stated the test strip vial label states the strips are lot 45392511 with expiration date 30-sep-2020.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The production process and production dates were investigated.It is not possible for test strip lot 45392511 expiration: 30-sep-2020 to be packed in an outer packaging of test strips that do not expire until 2023.The time difference of 3 years between expiry date of test strip vials and package is impossible.Retention material contains the correct code key.

• Brand Name: COAGUCHEK XS PT TEST
• Type of Device: PROTHROMBIN TIME 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: 14602036
• MDR Text Key: 293351431
• Report Number: 1823260-2022-01612
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 04625315003
• Device Lot Number: 56099311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• 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
• Patient Sequence Number: 1