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

Catalog Number 04625358019

Device Problem High Test Results (2457)

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

Event Date 12/10/2022

Event Type  malfunction  

Event Description

We received an allegation of questionable inr results for 1 patient tested with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.On (b)(6) 2022 the patient had a meter result of 2.3 inr while the lab result was 1.8 inr.The patient's coumadin dose taken was 7.5 mg based on the lab result.On (b)(6) 2022 the patient had an initial meter result of 2.9 inr while the lab result was 2.2 inr.The time difference between the tests was one hour.The patient's coumadin dose taken was 7.5 mg based on the lab result.The patient's therapeutic range was 2.35-2.75 inr.

Manufacturer Narrative

Initial reporter occupation is patient/consumer.The 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.The patient was informed about the possible effect of antibiotics on the measurement result from the coaguchek device.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.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16071010
• MDR Text Key: 308290787
• Report Number: 1823260-2022-04235
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2022

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: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 04625358019
• Device Lot Number: 60941617
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/29/2022
• 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: ALDACTON; CORDORAN; COROLAN; COUMADIN; DILATREND; ECO PRIN; FORSIKA; LASIX; MONODUR; PANTOPRAZOLE; SÜTRIL NEO; TAVANIC
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 63 KG