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

Catalog Number 04625374160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer questioned results from his coaguchek xs meter with serial number (b)(4) and performed 3 comparisons to the laboratory using the dade innovin method.The results from 1 comparison test were discrepant.The customer initially tested on the meter at 7:00 a.M.And the result was 2.6 inr.The result from the laboratory at 9:00 a.M.Was 2.0 inr.The customer isn't sure which of these results was correct.He reported the meter result to his doctor but the doctor considered the result from the laboratory to be correct.No treatment was received.The customer's therapeutic range is 2.0 ¿ 3.0 inr.No adverse event occurred.The customer feels fine.The customer is not anemic or polycythemic.The customer does not have antiphospholipid antibodies.The customer is not on direct thrombin inhibitors.The customer was on heparin 1 month ago while he was hospitalized for a hernia.The customer has not been ill recently.The customer has been taking regular doses of extra strength tylenol for a headache.The customer's coumadin dose has not changed.The customer has not had any diet changes and is not experiencing any bleeding or bruising.The meter and test strips were requested for investigation.Relevant retention test strips (lot 272164) were tested in comparison with the master lot coaguchek xs pt.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

The customer returned the meter for investigation.The returned meter was tested in comparison to a retention meter and masterlot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 3.0 inr, donor 2 inr: 2.4 inr.Donor 1 hct: 38%, donor 2 hct: 37%.Testing results: donor 1: retention meter with masterlot strips: 3.0 inr, customer meter with masterlot strips: 3.0 inr.Donor 2: retention meter with masterlot strips: 2.5 inr, customer meter with masterlot strips: 2.4 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.The investigation was unable to find a definitive root cause for this event.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7556262
• MDR Text Key: 109636859
• Report Number: 1823260-2018-01668
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 27216421
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN; OTHER MEDICATIONS - NOT PROVIDED; COUMADIN; OTHER MEDICATIONS - NOT PROVIDED
• Patient Age: 63 YR