FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK XS PT TEST PST
MDR report key: 25116329
·
Received May 7, 2026
Report
- Report Number
- 1823260-2026-01796
- Event Type
- Malfunction
- Date Received
- May 7, 2026
- Date of Event
- April 15, 2026
- Report Date
- May 7, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND HAS NOT BEEN RECEIVED AT THIS TIME. THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
ROCHE DIAGNOSTICS RECEIVED A CUSTOMER COMPLAINT REGARDING AN ALLEGED PACKAGING ISSUE WITH THE COAGUCHEK XS PT TEST PST, IN WHICH THE TEST STRIP DATA ON THE VIAL DOES NOT MATCH THE DATA ON THE CARDBOARD PACKAGING. TEST STRIP DATA FROM THE VIAL: REF: 07762798016, LOT: 90273012, EXP: 2027-05-31. TEST STRIP DATA FROM THE CARDBOARD PACKAGING: REF: 07404379016, LOT: 12523005, EXP. 2027-02-01.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141706 | COAGUCHEK XS PT TEST PST | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | 90273012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |