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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problems Coagulation Disorder (1779); Heart Failure (2206)

Event Date 09/02/2018

Event Type  Injury  

Manufacturer Narrative

Medwatch field occupation - the occupation is lay user/patient.

Event Description

The customer's daughter complained that questionable inr results from coaguchek meter serial number (b)(4).On (b)(6) 2018 the customer's legs "felt funny" and she was not walking properly.There was no action taken.On (b)(6) 2018 the result from the meter was 6.7 inr.The customer was not sure if the result was correct and her physician withheld her coumadin dose.On (b)(6) 2018 the customer went to her cardiologist.She was then sent to the emergency room and it was determined that she had a stroke on (b)(6) 2018.The customer was admitted to the hospital, taken off of coumadin, and treated with a heparin drip.The customer's inr was tested in the laboratory and the result was 4.0 inr.On (b)(6) 2018 the customer had a heart attack during physical therapy and was transferred to another hospital.On (b)(6) 2014 the customer was released from the hospital.The customer's therapeutic range was 2.5 - 3.5 inr.The customer was not anemic, no heparin, had no antiphospholipid antibodies, and no direct thrombin inhibitors.The customer has had no changes in diet, no changes in warfarin, no changes in medications, and no illness prior to the stroke.The customer stated that the stroke was caused by a clot and was caused by or contributed to by coaguchek meter.The customer stated the results from the meter were correct.Retention test strips (lot 281241-21) 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 the specification.The customer returned one test strip.The returned test strip was measured at the returned meter with liquid qc of a high level in comparison to masterlot #28632180 (recalibrated lot to rtf/09) on internal reference meter.Returned strip used qc 1: 2.5 inr.Retention strips used qc 2: 2.4 inr, qc 3: 2.5 inr.The obtained qc values were in the allowed range of the used combination master lot strip lot - qc lot.(1.9 - 2.9 inr).The obtained qc results were in the allowed range.No error messages occurred during the investigation.The investigation did not identify a product problem.

Manufacturer Narrative

The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips, there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.The information in the case is consistent with the details of the recall and the issue has been fully investigated.

• 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: 7948114
• MDR Text Key: 123117564
• Report Number: 1823260-2018-03504
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 28124121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Manufacturer Received: 09/16/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 09/16/2018
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES Z-0360-2019
• Patient Sequence Number: 1
• Treatment: CALCIUM; COUMADIN (WARFARIN); DIGOXIN; FENOFIBRATE; FISH OIL; LISINOPRIL; METOPROLOL; SIMVASTATIN; SPIRONOLACTONE; CALCIUM; COUMADIN (WARFARIN); DIGOXIN; FENOFIBRATE; FISH OIL; LISINOPRIL; METOPROLOL; SIMVASTATIN; SPIRONOLACTONE
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 55