MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-02-04 for HEMOCHRON JR. CITRATE APTT CUVETTE J103C manufactured by International Technidyne Corp..
[4432952]
Healthcare professional reports results higher than reference laboratory with hemochron jr. Citrated aptt cuvette assay for pt with admitting diagnosis of abdominal pain and cholecystitis. Hemochron jr. Citrated aptt test generated result of 113 seconds, which was higher than the physician's expectations. Sample tested at the reference laboratory and result was 47. 5 seconds. Pt management was based on the laboratory result. No adverse event(s) reported.
Patient Sequence No: 1, Text Type: D, B5
[11844785]
(b)(4).. Method: cuvette/single-use disposable. As part of itc's investigation, evaluation testing was performed on retain samples of a similar lot. Process evaluation performed. Review and trend analysis of finished product qc test data was performed. Manufacturing process reviewed. Result: an upward shift in non-heparinized blood response when compared to historical performance was identified. Conclusion: manufacturer notified fda on december 6, 2013 of the voluntary recall of (b)(4) lots of hemochron jr. Citrate aptt cuvettes. Itc's investigation into the product's performance identified that the affected lots of j103c cuvettes may recover higher than expected results in normal individuals. When testing non-heparinized (e. G. Normal blood samples), results may average higher than historic values. Test results performed on patients receiving heparin therapy are not affected. The upward shift in non-heparinized blood response is associated with a recent formulary optimization. Correction of the normal range shift being implemented to assure that test results from non-heparinized sampled in future lot releases will perform similar to historic experiences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2248721-2014-00004 |
| MDR Report Key | 3787201 |
| Report Source | 06 |
| Date Received | 2014-02-04 |
| Date of Report | 2014-01-07 |
| Date of Event | 2013-11-11 |
| Date Mfgr Received | 2014-01-07 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-05-22 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2250033-12/06/13-002 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON JR. CITRATE APTT CUVETTE |
| Product Code | GFO |
| Date Received | 2014-02-04 |
| Catalog Number | J103C |
| Lot Number | E3JCC014-P2 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-02-04 |