MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-29 for LIFETEC ELITE V1.0 manufactured by It Synergistics, Llc.
[51823381]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[51823382]
On 6/02/2016 it synergistics, (herein after itsy) was made aware of an issue from customer (b)(6), where the lifetec elite v1. 0 510(k) bk060032 did not apply a product level lab hold on a unit of blood on (b)(6) 2016 that had an associated positive test result, which allowed the suspect product to be sold. It has been determined that the initial positive laboratory test was confirmed negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435501-2016-00001 |
| MDR Report Key | 5834734 |
| Date Received | 2016-07-29 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-05-19 |
| Date Mfgr Received | 2016-06-02 |
| Device Manufacturer Date | 2006-08-21 |
| Date Added to Maude | 2016-07-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KALMAN GROF-TISZA |
| Manufacturer Street | 115 TREE ST |
| Manufacturer City | FLOWOOD MS 39232 |
| Manufacturer Country | US |
| Manufacturer Postal | 39232 |
| Manufacturer Phone | 8558667648 |
| Manufacturer G1 | IT SYNERGISTICS, LLC |
| Manufacturer Street | 115 TREE ST |
| Manufacturer City | FLOWOOD MS 39232 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 39232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIFETEC ELITE V1.0 |
| Generic Name | LIFETEC ELITE |
| Product Code | MMH |
| Date Received | 2016-07-29 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IT SYNERGISTICS, LLC |
| Manufacturer Address | 115 TREE ST FLOWOOD MS 39232 US 39232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-29 |