MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for PROCLEIX NAT TRACKER SOFTWARE V3.0 10009130 manufactured by Grifols Diagnostic Solutions Inc..
[101693113]
The original pool results were nonreactive for all of the samples. This issue was escalated to (b)(4) (nat tracker cmo). Both grifols and (b)(4) investigated the anomaly. The investigation included database simulations, review of the audit trail, error log, run report, and nat tracker software code. A network connectivity error occurred shortly before the incident. The assignment of reactive to the 17 samples occurred over a two second time period. The anomaly occurred prior to the transfer of the results to the customer lis. The assignment of reactive to a sample would only occur if an individual donor test (idt) or a manual change in the software had been performed. Review of the data from the procleix tigris instrument showed no idt samples and no reactive pools in the run. Review of the software audit trail showed no evidence of a manual data change. Neither grifols software engineering nor (b)(4) were able to duplicate the event on the nat tracker software. At the customer site, the grifols field service engineer and the customer were also unable to reproduce the results. The investigation could not determine a common link or scenario that would result in this anomaly. The assignment of the 17 samples as reactive was a remote occurrence that was not reproducible and has not previously been observed.
Patient Sequence No: 1, Text Type: N, H10
[101693114]
An incident occurred during the update of the run status from hold to valid. Seventeen samples from multiple pools were incorrectly assigned the conclusion of "reactive" after the procleix tigris instrument file was imported to procleix nat tracker software.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000124057-2018-00001 |
| MDR Report Key | 7307555 |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-01-18 |
| Date Mfgr Received | 2018-01-18 |
| Date Added to Maude | 2018-03-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ALISHA MCREYNOLDS |
| Manufacturer Street | 4560 HORTON STREET |
| Manufacturer City | EMERYVILLE CA 94608 |
| Manufacturer Country | US |
| Manufacturer Postal | 94608 |
| Manufacturer Phone | 5109235046 |
| Manufacturer G1 | GRIFOLS DIAGNOSTIC SOLUTIONS INC. |
| Manufacturer Street | 4560 HORTON STREET |
| Manufacturer City | EMERYVILLE CA 94608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROCLEIX NAT TRACKER |
| Generic Name | BLOOD ESTABLISHMENT COMPUTER SOFTWARE |
| Product Code | MMH |
| Date Received | 2018-03-01 |
| Model Number | SOFTWARE V3.0 |
| Catalog Number | 10009130 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRIFOLS DIAGNOSTIC SOLUTIONS INC. |
| Manufacturer Address | 4560 HORTON STREET EMERYVILLE CA 94608 US 94608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-01 |