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

Catalog Number 07671687016

Device Problem High Test Results (2457)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results for one patient tested with the coaguchek inrange meter compared to the laboratory method.On (b)(6) 2024: the laboratory result from the stago neoptimal laboratory method was 2.4 inr.  the meter result from the reporter's coaguchek inrange meter was 3.4 inr.The time between measurements was <3 hours.On (b)(6) 2024: the laboratory result from an unknown laboratory method was 2.5 inr.  the meter result from the reporter's coaguchek inrange meter was 3.2 inr.The meter result from an unspecified coaguchek retention meter was 3.5 inr.The time between measurements was not provided.The patient's therapeutic range is 2 to 3 inr.   .

Manufacturer Narrative

The serial number of the customer's coaguchek inrange meter is (b)(6).The serial number of the coaguchek retention meter was not provided.The patient was taking antibiotics at the time of the report.Product labeling states "the action of oral anticoagulants (coumarin derivatives) can be increased or weakened when other medication is taken simultaneously (e.G.Antibiotics, but also prescription-free medication like pain relievers, antirheumatic medication and medication against influenza).This, in turn, can also lead to either an increase or a decrease in prothrombin time (inr).If other medication is taken, it is recommended that the prothrombin time be checked more frequently and that the anticoagulant dose be subsequently adjusted." 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." e3 - occupation is patient/consumer.

• Brand Name: COAGUCHEK XS PT TEST PST
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19040808
• MDR Text Key: 340124877
• Report Number: 1823260-2024-01030
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2024

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 Catalogue Number: 07671687016
• Device Lot Number: 67810016
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/04/2024
• 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: ANTIBIOTICS; FLUINDION