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

Catalog Number 04625374160

Device Problem Low Readings (2460)

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

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation ni equals lay user/patient.

Event Description

The customer complained of 3 separate occurrences where they received questionable low inr results from their coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.At 8:00 am the result from the meter was 1.9 inr.At 10:00 am the result from the laboratory was 3.0 inr.On (b)(6) 2018 at 8:00 am the result from the meter was 1.5 inr.On (b)(6) 2018 at 10:00 am the result from the laboratory was 2.0 inr.On (b)(6) 2018 at 8:00 am the result from the meter was 2.5 inr.On (b)(6) 2018 at 10:00 am the result from the laboratory was 3.3 inr.The customer's therapeutic range is 2.5 - 3.5 inr.There was no allegation of an adverse event.The customer is receiving lovenox injections twice a day.The customer is no anemic, no antiphospholipid antibodies, not on direct thrombin inhibitors, no signs of bleeding or bruising, and no changes in diet or medication.The customer's meter and strips were requested for return.Retention test strips (lot 314048) were tested in comparison to masterlot #28632180 (recalibrated lot to rtf/09).For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention material complies with specification.The investigation is currently ongoing.

Manufacturer Narrative

The complained test strips have been calibrated against the who standard rtf/16 and the affected by recall.Corresponding retention test strips (lot 314048) were tested in comparison to masterlot #28632180 (recalibrated lot to rtf/09).The corresponding retention material complies with the specification, based on requirements of the regular retention testing process of the qc department.The retention material and comparable masterlot test strips did not show abnormalities.Investigations have indicated results are reliable from 0.8 to 4.5 inr, since the calibration data covers this measuring range very well.

• 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: 8045559
• MDR Text Key: 128261894
• Report Number: 1823260-2018-04112
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

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: 10/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 31404821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 12/14/2018
• 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: 72 YR
• Patient Weight: 60