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

Catalog Number 07762798003

Device Problem Low Readings (2460)

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

Event Date 08/08/2021

Event Type  malfunction  

Manufacturer Narrative

The returned test strips were measured on reference meters with a high-level control sample: all inr values were within the specified target ranges, confirming the functionality of the complained coaguchek test strips.Test 1: 2.9 inr, test 2: 2.8 inr, test 3: 2.9 inr.No error messages occurred.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 returned customer material and retention material complied with the specification.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." iniital reporter occupation was lay user/patient.

Event Description

There was an allegation of a questionable result from a coaguchek inrange meter.The serial number was requested but was not provided.In the morning at an unknown time, the result from a laboratory using an unknown reagent was 2.7 inr.At 7:15 am, the result from the meter was 1.6 inr.The therapeutic range was 2.0-2.5 inr.The testing frequency was not provided.

• Brand Name: COAGUCHEK XS PT TEST PST
• 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: 12617600
• MDR Text Key: 276147785
• Report Number: 1823260-2021-02962
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2021

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 Catalogue Number: 07762798003
• Device Lot Number: 46588512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2021
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/12/2021
• 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: 60 YR
• Patient Weight: 96