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

Catalog Number 04625315160

Device Problem High Test Results (2457)

Patient Problem Thromboembolism (2654)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

A routine retention testing process has been implemented.Valid retention results are available for all lots in the event a strip lot is alleged in a complaint.All retention data is reviewed on a monthly basis once testing is complete.If a failing result is observed during testing, appropriate actions will be taken.The customer¿s test strips were requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter alleged that a patient which had antiphospholipid antibodies had a questionable inr result from a coaguchek xs meter.The reporter stated that the result from the meter was within the patient's therapeutic range of 2.5 - 3.5 inr.The result from the meter and the meter serial number were requested but were not provided.The reporter alleged that after the result from the meter, the patient had a deep vein thrombosis.The comparison inr results prior to the day of the event, on the day of event, and after the day of event were requested but not provided.Information such as changes in dosage prior to the event, the timeline of the event, and the diagnostic or therapeutic measures due to the event were requested but were not provided.

Manufacturer Narrative

Request from fda: would you please provide the test strip lot number for report 1823260-2019-02647? are the test strip lots in the above report in the recall list? response from manufacturer: the initial reporter stated that she was provided a case where a patient received a result within the therapeutic range of 2.5-3.5 inr and suffered a dvt following the result.The patient had anti-phospholipid antibodies (apas), so the initial reporter believes that the apas may have led to the customer receiving erroneous result.The initial reporter had no information about the meter, the strips being used or any additional information about the case.The initial reporter stated that she will have a nurse call in to roche to provide more information regarding the case.At this point roche has not received a call from the nurse and multiple calls from roche to the initial reporter for additional information have not been successful.The coaguchek package insert states in the "limitations of procedure" section that "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) can potentially lead to prolonged clotting times, i.E.Elevated inr values.A comparison to apa-insensitive laboratory method is recommended if the presence of apas is known or suspected." there is also a reference the following journal article: moll s and ortel tl monitoring warfarin therapy in patients with lupus anticoagulants.Annals of internal medicine 1997;127:177-185.

• 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: 8806721
• MDR Text Key: 151565513
• Report Number: 1823260-2019-02647
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04625315160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other