MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-05 for HEMOCHRON JR. CITRATE APTT CUVETTE J103C manufactured by International Technidyne Corp..
[4048002]
Healthcare professional reports higher than expected results with hemochron jr. Citrated aptt cuvette assay. During pre-operative screening for an unspecified procedure, the aptt test generated result of 72 plasma equivalent second and a repeated test generated 74 plasma equivalent seconds, which were both higher than expected. The healthcare facility's expected normal range is 21-35 seconds. A sample was tested at the reference laboratory for confirmation and results was 36 seconds. The patient was evaluated based on the laboratory result. No adverse event(s) reported.
Patient Sequence No: 1, Text Type: D, B5
[11497297]
(b)(4). Method: actual device not evaluated (cuvette/single-use disposable). Result: results pending completion of evaluation. Conclusion: conclusion not yet available - evaluation in progress. Itc has requested all date required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2013-00060 |
| MDR Report Key | 3561106 |
| Report Source | 06 |
| Date Received | 2013-11-05 |
| Date of Report | 2013-10-08 |
| Date of Event | 2013-10-01 |
| Date Mfgr Received | 2013-10-08 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-02-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR FOX |
| Manufacturer Street | 20 CORPORATE PLACE S |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer Street | 6-8 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 | 2013-11-05 |
| Catalog Number | J103C |
| Lot Number | E3JCC013-P1 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-05 |