MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-14 for HEMOCHRON JR. CITRATE APTT CUVETTE J103C manufactured by International Technidyne Corp.
[17385348]
Healthcare professional reports inconsistent results and results higher than reference with the hemochron jr. Citrated aptt cuvette assay. Pt being evaluated for ischemic stroke with symptoms of right side facial droop and weakness on right side. The healthcare facility's criteria to administer tissue plasminogen activator (tpa) is in part based on aptt results targeted at greater than or equal 38. 6 seconds. Repeated hemochron jr. Citrated aptt tests generated results of 46. 8, 39. 3, and 38. 3 plasma equivalent seconds. Sample sent to the reference laboratory for result confirmation generated 30. 7 seconds. The pt was evaluated and treated based on the laboratory result. No adverse event(s) reported.
Patient Sequence No: 1, Text Type: D, B5
[17712850]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2013-00063 |
| MDR Report Key | 3577043 |
| Report Source | 06 |
| Date Received | 2013-11-14 |
| Date of Report | 2013-10-21 |
| Date of Event | 2013-10-01 |
| Date Mfgr Received | 2013-10-21 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR FOX |
| Manufacturer Street | 20 CORPORATE PLACE SOUTH |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer Street | 8 OLSEN AVE |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR. CITRATE APTT CUVETTE |
| Product Code | GFO |
| Date Received | 2013-11-14 |
| Returned To Mfg | 2013-10-25 |
| Catalog Number | J103C |
| Lot Number | F3JCC015-P3 |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-14 |