FDA Adverse Event
Malfunction
Summary report: N
COAGUCHEK ® XS SYSTEM
MDR report key: 3173524
·
Received June 17, 2013
Report
- Report Number
- 1823260-2013-03635
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 13, 2013
- Report Date
- July 24, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- GJS
- PMA / PMN Number
- K062925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
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 HOME HEALTH NURSE TESTED A PATIENT CAPILLARY SAMPLE ON THE COAGUCHEK XS SYSTEM AND OBTAINED A RESULT OF 6.8 INR. WITHIN 4 HOURS, A VENOUS SAMPLE OBTAINED FROM THE SAME PATIENT, REPORTEDLY MEASURED 4.5 INR ON AN UNSPECIFIED LABORATORY INSTRUMENT. BASED ON THE LABORATORY RESULT, PATIENT'S PHYSICIAN WITHHELD COUMADIN DOSE. NO ADVERSE EVENT ASSOCIATED WITH THE ALLEGED MALFUNCTION WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272924 | COAGUCHEK ® XS SYSTEM | PROTHROMBIN TIME TEST STRIPS | GJS | ROCHE DIAGNOSTICS | NA | 21512412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 065 YR | B COMPLEX VITAMIN| FOSAMAX| BENICAR HCT| NICOTINE, TOPICAL| HYDROCODONE| ATORVASTATIN| DIAZEPAM| CYANOCOBALAMIN| CALCIUM CARBONATE| ADVAIR INHALER| ALBUTEROL INHALER| WARFARIN| DILITIAZAM| VITAMIN D3| LORATADINE| DULOXETINE| FISH OIL| DIVALPROEX |