MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-08 for PAKPLUS 303469 manufactured by Immucor Gti Diagnostics, Inc..
[99992162]
Customer complaint ((b)(4)) was received 09 jan 2018. On (b)(6) 2017, customer tested fresh patient sample with lot 3005747 of pakplus and received a negative result for well a. Customer received new lot of pakplus 3006225 on (b)(6) 2018. On (b)(6) 2018, customer testing with lot 3006225 of pakplus on a patient aliquot from (b)(6) 2017. The result for well a was positive. Customer also tested another patient aliquot collected from (b)(6) with lot 3005747 and well a was negative. Testing was repeated on (b)(6) 2018 using both lots. Lot 3005747 resulted in well a negative and lot 3006225 resulted in well a positive. Customer reported negative results on the patient from the initial testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00003 |
| MDR Report Key | 7257347 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-08 |
| Date of Report | 2018-01-05 |
| Date of Event | 2018-01-05 |
| Date Mfgr Received | 2018-01-09 |
| Device Manufacturer Date | 2018-01-03 |
| Date Added to Maude | 2018-02-08 |
| 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. STEPHEN CONRAN |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541016 |
| Manufacturer G1 | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53186 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAKPLUS |
| Generic Name | PAKPLUS |
| Product Code | MYP |
| Date Received | 2018-02-08 |
| Catalog Number | 303469 |
| Lot Number | 3006225 |
| Device Expiration Date | 2018-08-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 53816 US 53816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-08 |