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

Catalog Number 04625358019

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The customer¿s products have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.Routine retention testing was performed and passed the internal inspection.Retention testing data is reviewed and appropriate actions are taken as needed.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods." this event occurred in (b)(6) unique identifier (udi) #(b)(4).Occupation was lay user/patient.

Event Description

There was an allegation of a questionable result from coaguchek xs meter serial number (b)(4).The result from the meter was 5.3 inr and the result from the laboratory using an unknown reagent was 3.06 inr.The finger was squeezed at the time of testing.The therapeutic range was 3.0-3.5 inr.

Manufacturer Narrative

The reporter's strips were returned for investigation.The returned product was measured in comparison to a retention meter and master lot strips.Testing results (qc range: 2.7 - 3.3 inr): qc 1: 2.9 inr, qc 2: 2.9 inr, qc 3: 2.8 inr, all inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.Medwatch fields d9 and h3 have been updated.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11406215
• MDR Text Key: 246240818
• Report Number: 1823260-2021-00647
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 04625358019
• Device Lot Number: 48020117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 77