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

Catalog Number 04625358019

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Paralysis (1997)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The patient complained of "wrong results" from coaguchek xs meter serial number (b)(4).The patient alleged that based on the "wrong results" she took the wrong coumadin and coraspin dosage and then suffered from paralysis on one side of her body.Information was provided as "the patient had already on the left side of her body a paralysis and now she have on both side a paralysis".It was unclear when the paralysis occurred.Clarification was requested but was not provided.The patient was then admitted to the intensive care unit.Multiple requests for additional information about the event were made, but no additional information was provided.On (b)(6) 2018 at 08:00 pm, the result from the meter was 5.1 inr.On (b)(6) 2018 at 08:10 pm, the result from the meter was 3.7 inr.The same finger was used.On (b)(6) 2018 at 09:00 pm, the result in the laboratory was 2.1 inr.The laboratory method was not provided.On (b)(6) 2018 at 08:00 pm, the result from the meter was 2.1 inr.The patient then took 2.5 mg of coumadin and 100 mg of coraspin.On (b)(6) 2018 at 06:00 pm, the result from the meter was 3.4 inr.On (b)(6) 2018 at 09:00 pm, the result in the laboratory was 2.04 inr.The laboratory method was not provided.On (b)(6) 2018 at 00:00 am, the result in the laboratory was 2.0 inr.The laboratory method was not provided.On (b)(6) 2018 at 00:30 am, the result from the meter as 2.0 inr.The patient then took 2.5 mg of coumadin and 100 mg of coraspin.On (b)(6) 2018 at 11:00 am, the result in the laboratory was 2.15 inr.The laboratory method was not provided.The therapeutic range was 2.0-3.0 inr.The patient is no longer taking coumadin.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Retention material complies with specification.The meter was checked and was found to be working properly.The patient was given a new meter.

Manufacturer Narrative

On (b)(6) 2018 at 09:00 pm the laboratory method was "diapt as reaktif".

Manufacturer Narrative

Relevant retention test strips (lot 250323) were tested in comparison with the master lot coaguchek xs pt.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable and there were no error messages.The investigation was unable to find a definitive root cause.

Manufacturer Narrative

The customer's returned meter was tested with retention test strips in comparison to the current master lot strips.Two human blood samples from warfarin donors and internal reference meters were used.  testing results:  donor #1: master lot and reference meter: 2.7 inr , donor #1: customer meter and retention test strip: 2.2 inr.Donor #2: master lot and reference meter: 3.0 inr  , donor #2: customer meter and retention test strip: 2.6 inr .The returned material and the retention material meet 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
• 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: 7302211
• MDR Text Key: 101171709
• Report Number: 1823260-2018-00597
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625358019
• Device Lot Number: 250323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 02/02/2018; 02/02/2018; 02/02/2018
• Supplement Dates FDA Received: 04/11/2018; 05/01/2018; 05/02/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CORASPIN; COUMADIN
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 75