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

Catalog Number 04625374160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of erroneous inr results on his coaguchek xs meter with serial number (b)(4) when compared to the laboratory using the dade innovin method.The customer tested on his meter at either 10:31 a.M.Or 11:31 a.M.And obtained a result of 2.6 inr.The qc check mark was observed for this test.The customer was tested "within minutes" on the doctor¿s non-roche meter and the result was 3.8 inr.The customer had a result of 3.5 inr from the laboratory using the dade innovin method.The sample was obtained "within minutes" of the finger stick result from the customer¿s meter.The doctor adjusted the customer¿s warfarin dose based on the 3.5 inr result from the laboratory.The customer had been advised to not take warfarin for 1 day based on a result of 4.3 inr from the laboratory on (b)(6) 2016.The customer¿s therapeutic range is 2-3 inr.No adverse event occurred.The customer is feeling fine.The customer is not on heparin or direct thrombin inhibitors.The customer has no antiphospholipid antibodies.The customer is not taking any new medications and has had no changes in diet.The customer has had no additional illnesses and is not experiencing any bleeding or bruising.The meter and strips were requested for investigation.Replacements were sent.

Manufacturer Narrative

The customer returned the meter and test strips.The returned meter and strips were tested in comparison to a retention meter & masterlot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor #1 hct: 42%, donor #2 hct: 47%.Donor #1 master lot: 2.4 inr, donor #1 customer's strips and customer's meter: 2.5 inr.Donor #2 master lot: 3.8 inr, donor #2 customer's strips and customer's meter: 3.8 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet the specification.Relevant retention test strips (lot 128043-21) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 124158-80).For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention material was acceptable.

• 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: 6192669
• MDR Text Key: 62919522
• Report Number: 1823260-2016-02029
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

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: 10/31/2017
• Device Catalogue Number: 04625374160
• Device Lot Number: 12804321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• 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: WARFARIN
• Patient Age: 76 YR
• Patient Weight: 91