MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PT TEST; TEST, TIME, PROTHROMBIN

Lot Number 28632021

Device Problem Nonstandard Device (1420)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 11/02/2018

Event Type  Death  

Event Description

September 2018, we received a letter informing us that we received a shipment of test strips that are approved for continued use; however, any inr results greater than 4.5 would need to be confirmed with another test method.Later, we received replacement test strips with a new lot number (lot #28632021).Despite normal to slightly elevated inr testing results, the pt had a stroke, needing subsequent emergency thrombectomy on (b)(6) 2018.The pt died on (b)(6) 2018 from the resulting injury.We received a letter dated 11/05/2018 a few days later with notification that the strips were being recalled, and to immediately discontinue use.

• Brand Name: COAGUCHEK XS PT TEST
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8208325
• MDR Text Key: 131909272
• Report Number: MW5082708
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/28/2018

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: No Information
• Device Expiration Date: 06/30/2019
• Device Lot Number: 28632021
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 87 YR
• Patient Weight: 54