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 Consequences Or Impact To Patient (2199)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The patient stated his finger may have been squeezed excessively at the time of testing.The meter and test strips were provided for investigation where they were tested using retention controls.Vial #1 testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.5 inr, qc 2: 2.5 inr, qc 3: 2.5 inr.Vial #2 testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.5 inr, qc 2: 2.5 inr, qc 3: 2.5 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 results alleged by the customer were found in the meter¿s patient result memory with the time and date set incorrectly.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." unique identifier (udi) #(b)(4).

Event Description

There was an allegation of a questionable result from coaguchek xs meter serial number (b)(4).Around 8:06 am, the laboratory result using neoplastin reagent was 2.6 inr.Around 9:00-9:30 am, the meter result was 4.4 inr.The therapeutic range was 2.0-3.0 inr and the patient tests every two weeks.

• 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: 11417466
• MDR Text Key: 243221130
• Report Number: 1823260-2021-00657
• Device Sequence Number: 1
• Product Code: GJS
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2021

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: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 04625315160
• Device Lot Number: 42401011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/04/2021
• 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
• Patient Age: 68 YR
• Patient Weight: 83