MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

Catalog Number 04625412019

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(4).Occupation is lay user/patient.The test 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.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant inr results with coaguchek xs meter serial number (b)(4) compared to itself.The result from the meter at 11:17 a.M.Was 3.7 inr.The result from the meter at 11:22 a.M.Was 2.2 inr.The patient's therapeutic range was 2.0 - 3.0 inr.

Manufacturer Narrative

The customer's strips were returned for investigation.The returned product was measured with a retention meter in comparison to a retention meter and master lot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor 1 inr: 3.8 inr , donor 2 inr: 2.8 inr.Donor 1 hct: 48% , donor 2 hct: 44%.Testing results: donor #1: retention meter and master lot strips: 3.8 inr , retention meter and customer strips: 3.9 inr.Donor #2: retention meter and master lot strips: 2.8 inr , retention meter and customer strips: 2.8 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.Medwatch fields d4 (lot number and expiration date), d10 and h3 have been update.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9637323
• MDR Text Key: 219782293
• Report Number: 1823260-2020-00211
• 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: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 04625412019
• Device Lot Number: 35350211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADCAL - CALCIUM.; MAGNESIUM.; OMEGA 3.; PRIMROSE OIL.; VITAMIN C.; VITAMIN D.