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

Model Number XS PST

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient's daughter stated that coaguchek xs meter serial number (b)(4) was dropped during the month of (b)(6) 2017.She stated that she did not know exactly when the meter was dropped.While troubleshooting the concern, the meter memory was checked.Checking the meter memory, there were questionable results.The first result seen was as expected, 1.3 inr on (b)(6) 2017.Two additional results of 1.3 inr were in the meter memory from (b)(6) 2017, however the patient had only been tested one time that day.A display check of the meter was then completed.All segments were displayed on the display.The customer indicated that the bottom right segment on the left most "8" was "digitized or pixelated", but clearly visible.No issues were identified with the display.The customer then returned to checking the meter memory for additional issues.The following results were displayed upon re-check of the meter memory: (b)(4).The customer stated she was very certain that the first result (result 1) was displayed as 1.3 inr when checking initially, but the result display changed to 1.4 inr upon re-check.The customer was unable to verify if the patient tested more than once on (b)(6) 2017 and (b)(6) 2017.The patient stated no adjustments had been made to the date or time on them meter a meter result from (b)(6) 2017 was considered to be erroneous.The customer did not know which value from (b)(6) 2017 was reported.The customer stated that she did not believe that any of the 1.3 inr results were correct.The patient's warfarin dosages were raised when values of 1.3 inr were reported.The customer believes that the date and time posted for each result in the meter memory is inaccurate and stated that the patient did not perform more than one test in a day.No adverse events were alleged to have occurred with the patient.The patient's therapeutic range is 2.0 - 3.0 inr.The patient has had no new illnesses, medication, or diet changes over the time period in question.The patient does not have anemia and does not suffer from antiphospholipid antibodies.The patient does not take heparin or direct thrombin inhibitors.The patient's product was requested for investigation and replacement product was sent to the patient.The lot number and expiration date of the test strips that were used was requested but was unknown.

Manufacturer Narrative

The customer's meter was provided for investigation.Samples from two donors were tested on the meter with master lot test strips.The meter produced an error but no result after dosing with blood.There were no obvious signs of contamination to the meter.

Manufacturer Narrative

Upon review of the meter memory, the last two lot numbers of test strips that were used on the meter were lot numbers 18686410 and 18686510.Relevant retention test strips (lot 186864-10 and 186865-10) 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 samples were within specifications.The customer allegation of back-to-back values of 3.1 inr / 1.3 inr could not be reproduced or confirmed.These data were not present in the patient log.Overall, there are no inconsistent / fluctuating entries in the patient log.It was noted that patient inr results over the previous weeks were frequently below 2 inr, even though the therapeutic range is 2-3 inr.Measurements with a control solution were performed and the measurement was partially aborted, with an error.Failure analysis of the device electronics was performed.The circuit board was checked for contamination and damage.A current leakage was detected on the printed circuit board, caused by flux residues at the soldering points of the test strip connector.This issue may lead to errors.Medwatch has been updated.

• 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: 6647770
• MDR Text Key: 77842963
• Report Number: 1823260-2017-01259
• 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: 08/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• 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: 86 YR
• Patient Weight: 91