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

Model Number XS PST

Device Problem Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of erroneous inr results on coaguchek meter with serial number (b)(4).The customer initially tested on the meter and obtained a result of 6.2 inr at 9:00 a.M.The customer reported this result to her healthcare provider.The customer discovered that she was using expired test strips at the time of this result.The customer alleged that the meter did not produce an error message at the time of the erroneous result while using expired strips.The customer stated the time and date was set correctly and she was using the correct code key at the time of the 6.2 inr result.The customer switched to a new, non-expired vial of test strips and re-tested on the meter using a different finger at 10:00 a.M.And obtained a result of 1.8 inr.This result was also reported to the customer¿s healthcare provider.The customer re-tested again using another different finger at 10:30 a.M.And obtained a result of 1.8 inr.The customer and her doctor believe the result of 1.8 inr was correct.The customer¿s therapeutic range is 2.0 3.5 inr.No adverse event occurred.The customer feels ok.The new, non-expired test strip lot number was 15288123 with an expiration date of 28-feb-2018.The meter has never been cleaned.The customer has no hct issues and does not have antiphospholipid antibodies.The customer¿s coumadin dose has not been changed nor has her diet changed.She has bruises frequently and sometimes bleeding, however, no medical treatment has been necessary.The meter and test strips were requested for investigation; however, neither strip vial is available for return.Relevant retention test strips (lot 152881-23) 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.

Manufacturer Narrative

A specific root cause was not identified for this event.The customer has not returned the meter or test strips.No information was provided in the complaint that would point to a cause for the discrepant results.None of the customer's medications are currently known to interfere with the accuracy of test results.As no product was returned, the investigation could not be completed.

Manufacturer Narrative

The meter was returned.The test strips were not returned.The returned meter and master lot strips were tested 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: 2.5 inr.Donor #2 inr: 2.5 inr.Donor #1 hct: 45%.Donor #2 hct: 54%.Donor #1: master lot: 2.5 inr.Donor #1: master lot strip and customer meter: 2.3 inr.Donor #2: master lot: 2.5 inr.Donor #2: master lot strip and customer meter: 2.6 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.No information was provided in the complaint that would point to a cause for the discrepant results.A specific root cause was not identified for this event.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 6869298
• MDR Text Key: 87307563
• Report Number: 1823260-2017-02005
• 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,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 04837738001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• 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
• Patient Age: 59 YR