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

Catalog Number 07671687003

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Occupation was lay user/patient.Unique device identifier (udi) (b)(4).The test strips were requested to be returned for investigation, however, the strips were no longer available to return.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Test strip retention samples passed the internal inspection.

Event Description

We received a report of a questionable result on a coaguchek inrange meter serial number (b)(4) when compared to a second meter, serial number unknown.The result on the doctor's meter at 10:00 am was 2.6 inr.The result on the patient's meter at 10:30 am was 1.9 inr.The patient's therapeutic range was 2.0-3.0 inr.

Manufacturer Narrative

The meter was returned for investigation, however, the test strips were no longer available.Retention test strips were measured using the returned meter with two high-level control samples: control sample lot 45569900 result (qc range = 2.7-3.3 inr) qc 1: 3.1 inr, qc 2: 3.1 inr, qc 3: 3.1 inr.Control sample lot lin 3 control 60022 result (qc range=4.1-6.8 inr) qc 1: 5.7 inr, qc 2: 5.5 inr, qc 3: 5.4 inr.The obtained results were in the allowed range.No error messages occurred during the investigation.Returned customer material and retention material comply with the specification.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11413081
• MDR Text Key: 257333231
• Report Number: 1823260-2021-00648
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K170960.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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: 07671687003
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELTOROXIN; INSIDON; ISOPROLOL; KRATEGUT; MAGNESIUM; SELEN; VITAMINE C; ZINK
• Patient Age: 62 YR
• Patient Weight: 56