MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for ANTI-A1 LECTIN 0012280 manufactured by Immucor, Inc..
[61096218]
The use of this product is either by manual test tube or slide method only. The customer site did not return to immucor any remaining customer site lectin product or red blood cell samples under test at the customer site, so the immucor laboratory was unable to investigate the items. Also, because the use of this product is either by manual test tube or slide method only, then immucor technical support could not access any automated test well images using a remote electronic connection method.
Patient Sequence No: 1, Text Type: N, H10
[61096219]
On (b)(6) 2016, a customer reported unexpected positive results when using anti-a1 lectin by tube methodology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2016-00312 |
| MDR Report Key | 6126074 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2016-10-27 |
| Device Manufacturer Date | 2016-01-11 |
| Date Added to Maude | 2016-11-23 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR HOWARD YOREK |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal | 300915625 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 300915625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANTI-A1 LECTIN |
| Generic Name | BLOOD GROUPING LECTIN |
| Product Code | KSI |
| Date Received | 2016-11-23 |
| Catalog Number | 0012280 |
| Lot Number | 980012 |
| Device Expiration Date | 2018-02-12 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 300915625 US 300915625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-23 |