FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3884696
·
Received June 19, 2014
Report
- Report Number
- 1823260-2014-04485
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 22, 2014
- Report Date
- July 25, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER TESTED 7.8 INR ON THE COAGUCHEK XS SYSTEM WHILE 2 COMPARISON LABS FROM 2 DIFFERENT LOCATIONS RETURNED AS 5.0 INR AND 5.5 INR. NO TREATMENT REQUIRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361169 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 22320522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 043 YR | METOPROLOL| ZIAGEN| OXYCODONE| COUMADIN| OXYCONTIN| ISENTRESS| DIGOXIN| LEXIVA| ONDANSETRON| APRAZOLAM| BIVAD| FERROUS SULFATE| OMEPRAZOLE| SANDOSTATIN LAR| MAGNESIUM OXIDE| LEVOTHYROXINE |