MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-01-26 for PF4 ENHANCED ASSAY X-HAT45 manufactured by Immucor Gti Diagnostics, Inc..
[36964042]
Capa(b)(4) was initiated on 01-30-2013 to track additional investigation across product lines, which included evaluation of all complaints for low positive controls, subsequent field action/recall activities, and additional investigation to determine root cause and implement corrective and preventive actions, based on root cause determination. Cross-functional root cause analysis activities performed as part of the investigation determined root cause to be insufficiently detailed operating procedures. The manufacturing operators failed to properly evaluate potentially impacted plates when the pf4:pvs complex ran out at the end of the manufacturing run because of insufficiently detailed oyster bay equipment and plate manufacturing procedures. The addition of insufficient quantity of pf4:pvs complex to the plates lead to variation in reactivity, which in turn could lead to potential invalid assay or false negative result. An invalid assay would not result in significant harm to patient. A false negative result could contribute to a delay in diagnosis and initiation of alternative therapies, and may increase the risk of complications. A voluntary medical device recall was initiated on 02-04-2013, for pf4 enhanced assay lot 3000389. At the time of initiation of recall, there was no product remaining in inventory. The effectiveness check of customer contact was completed in june 2013, with 100% of consignees confirming receipt of the recall notification and confirming disposition of affected product. The recall was reported to us fda as required by 21 cfr 7. 53 (recall status reports), and medical device recall report number is 2183608-02/15/13-001-r. Several corrective actions were implemented to resolve the issue and prevent recurrence, as listed below: created additional instructions for triaging errors that occur during plate manufacture improved manufacturing documentation by requiring a written description of production events and operator actions performed during a manufacturing run. Increase qc sampling. Implement volume checks to better detect a failure. Improve the training program for equipment operators. Modify manufacturing processes to eliminate potential failure points. Re-evaluate placement & function of error detectors on manufacturing equipment. Evaluate the validation performed for the obpw and identify gaps needing remediation.
Patient Sequence No: 1, Text Type: N, H10
[36964043]
A customer complaint was received on(b)(6) 2013 ((b)(4)), where customer informed about not getting consistent replicate results with pf4 enhanced assay lot 3000389, run on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2016-00001 |
| MDR Report Key | 5391071 |
| Report Source | USER FACILITY |
| Date Received | 2016-01-26 |
| Date of Report | 2013-01-15 |
| Date of Event | 2013-01-14 |
| Date Mfgr Received | 2013-01-15 |
| Device Manufacturer Date | 2012-10-15 |
| Date Added to Maude | 2016-01-26 |
| 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. PADMINI SAHOO |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 531864054 |
| Manufacturer Country | US |
| Manufacturer Postal | 531864054 |
| Manufacturer Phone | 2627541005 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2183608-02/15/13-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PF4 ENHANCED ASSAY |
| Generic Name | PF4 ENHANCED ASSAY |
| Product Code | LCO |
| Date Received | 2016-01-26 |
| Model Number | NA |
| Catalog Number | X-HAT45 |
| Lot Number | 3000389 |
| Device Expiration Date | 2014-08-15 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 531864054 US 531864054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-26 |