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

Catalog Number 04625315160

Device Problem High Test Results (2457)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

The meter and test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.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.".

Event Description

The initial reporter received questionable inr results with coaguchek xs plus meter serial number with (b)(4) compared to a laboratory using a stago neoplastin method.On (b)(6) 2021, the result from the meter was 3.8 inr.The result from the laboratory at the same time was 2.8 inr.On (b)(6) 2021, the result from the meter was 3.8 inr.The result from the laboratory at the same time was 2.7 inr.Both comparisons were for the same patient.The patient¿s therapeutic range is 2.0-3.0 inr.The quality controls were within range for both levels.

Manufacturer Narrative

The customer's returned meter powered on without difficulty using fresh retention batteries.The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Vial #1 testing results (qc range = 2.4 - 3.6 inr): qc 1: 2.9 inr qc 2: 3.0 inr qc 3: 3.0 inr.Vial #2 testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr qc 2: 3.0 inr qc 3: 3.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The customer's power allegation could not be reproduced.The returned meter performed according to specification using fresh retention batteries.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: 13120406
• MDR Text Key: 287586882
• Report Number: 1823260-2021-03949
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702128101
• UDI-Public: 00365702128101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 04625315160
• Device Lot Number: 54146311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 02/09/2022
• 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
• Treatment: ASPIRIN; CALCIUM; DIGOXIN; HYDROXYUREA; METOPROLOL; SELEXA; TRAZODONE; WARFARIN
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 90 KG