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

Model Number XS PST

Device Problem Device Handling Problem (3265)

Patient Problems Overdose (1988); Hematuria (2558)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported he received a result of 9 when testing with his coaguchek xs meter.  the patient was instructed to check the meter memory and it was determined the value was in units of % quick instead of inr. the patient was advised %quick units are not used in the united states. the patient updated the units of measure on the meter to inr. the 9 %quick result was actually a 5.3 inr value.The patient said that he was normal, but had blood in his urine that day.He did not seek treatment.The patient stated he was going to call the physician to find out what to do with his medication dosage.The patient then mentioned on (b)(6) 2017, he obtained a value of 1.6 on the meter and his physician changed his warfarin dose. when checking the meter memory, the value observed on (b)(6) 2017 was 3.0 inr.The 3.0 inr value corresponded to a 16 % quick result.The patient had reported the16% quick value to the doctor as a 1.6 inr.Because of this, the doctor increased the patient's dose of warfarin from 5 mg five times per week/2.5 mg twice per week to 5 mg five times per week/10 mg twice per week.The patient's therapeutic range is 2 - 3 inr.The patient's testing frequency is weekly.The patient is not anemic and does not suffer from antiphospholipid antibodies.The patient does not take heparin or direct thrombin inhibitors and has had no new medications.The patient has had no changes in diet and no illnesses.Other than blood in his urine on (b)(6) 2017, the patient had no other symptoms of bruising.The test strip lot in use on (b)(6) 2017 was 17618921, with an expiration date of 05/31/2018.The patient's product was requested for investigation and replacement product was sent to the patient.The default setting for units of measure for the meter is inr. units of measure are displayed on the meter when the result is displayed.Relevant retention test strips (lot 176189-21) 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 samples were acceptable.Upon review of the meter memory during investigations, a discrepancy in results from 2014 was also observed. on (b)(6) 2014 the inr value at 08:58 was 2.3.Testing performed 24 minutes later gave a result of 1.6 inr.No further information was provided with regards to this discrepancy.

Manufacturer Narrative

The customer's test strips and meter were provided for investigation.The customer's meter and strips were tested using retention quality controls (range = 2.2 -3.4 inr).Test results: qc #1: 2.7 inr, qc #2: 2.5 inr.The obtained qc values were in the allowed range of the used combination strip lot/control lot.All measurements were without error messages.The returned material meets specifications.Since the customer was being treated as if his inr was low, his warfarin dose was increased and his inr subsequently increased as would be expected.None of the patient's treatments/medications are known to interfere with the accuracy of the test results.The meter comes from the factory with the display units set to inr, so the only way the meter displays results in %q is if the settings in the meter are changed by the customer.The results on the display appear very clearly with "inr/sec" or "%q" next to the result indicating the unit of measure being displayed.

• 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: 6637362
• MDR Text Key: 77501429
• Report Number: 1823260-2017-01224
• 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: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2017
• 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 Outcome(s): Other
• Patient Age: 84 YR