FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3173515
·
Received June 17, 2013
Report
- Report Number
- 1823260-2013-03636
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 3, 2013
- Report Date
- August 8, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
IT IS NOT KNOWN IF THE INITIAL REPORTER HAS OR INTENDS TO REPORT THE EVENT TO FDA.
Description of Event or Problem · 1
REPORTER STATED THAT A PATIENT CAPILLARY SAMPLE, TESTED ON THE COAGUCHEK XS SYSTEM, MEASURED 4.5 INR WITHIN 2 HOURS OF AN ADDITIONAL SAMPLE (TYPE NOT PROVIDED), OBTAINED FROM SAME PATIENT, MEASURING 3.3 INR ON AN UNSPECIFIED LABOARATORY INSTRUMENT. NO ACTION BASED ON THE COAUGHCHEK XS SYSTEM RESULT WAS REPORTED AND NO ADVERSE EVENT OCCURRED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272921 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21821522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 062 YR | PROTONIX| AMBIEN| XANAX| OXYCODONE| SEROQUEL XR| CYMBALTA| LASIX| LISINOPRIL| NORVASC| COUMADIN |