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

Catalog Number 04625315003

Device Problem High Readings (2459)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

The test strips were requested for investigation and have 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 method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods." occupation is lay user/patient.

Event Description

There was an allegation of a questionable inr result for one patient tested with coaguchek xs meter with serial number (b)(4) compared to an unknown laboratory method.The result from the meter at 7:30 was 3.4 inr.The laboratory result at 8:00 was 2.6 inr.The patient's interval for testing is once to twice a week.The patient's therapeutic range is 1.8 - 2.8 inr.

Manufacturer Narrative

The returned test strips were measured on reference meters with a high level control sample.Testing results (qc range: 2.5 - 3.1 inr): qc 1: 2.9 inr.Qc 2: 2.8 inr.Qc 3: 2.8 inr.All inr values were within the specified target ranges, confirming the functionality of the complained coaguchek test strips.No error messages occurred.Medwatch fields d9 and h3 have been updated.

• 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
• MDR Report Key: 12545612
• MDR Text Key: 273755545
• Report Number: 1823260-2021-02841
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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 Expiration Date: 05/31/2021
• Device Catalogue Number: 04625315003
• Device Lot Number: 43492812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APYDAN EXTENT; BRIVIIAKT; DESLORATADIN,; ELTHRYOXIN; FYCOMPA; PHENPFIBRAT; PHENPROGAMMA 3; TARGRETIN (CHEMO); APYDAN EXTENT; BRIVIIAKT; DESLORATADIN,; ELTHRYOXIN; FYCOMPA; PHENPFIBRAT; PHENPROGAMMA 3; TARGRETIN (CHEMO)
• Patient Age: 58 YR
• Patient Weight: 78