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

Model Number XS PST COAGUCHEK

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  No Answer Provided  

Event Description

E-mail from roche diagnostics instructing us not to use the test strips from specific lot #'s.Coaguchek xs pt strips used in coaguchek xs pst.

• Brand Name: ROCHE DIAGNOSTICS XS PST
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8070548
• MDR Text Key: 127342056
• Report Number: MW5081227
• 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: Patient
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: XS PST COAGUCHEK
• Device Lot Number: 31404821 (TEST STRIPS)
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 100