MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-10-04 for IMMUADD * manufactured by Immucor, Inc..
[16199753]
The customer sent patient specimen from 11/2005 for investigational testing; less than 1 ml (9 drops) of serum was received. Additional specimen was requested but not received. The k and e antgen reactivity was confirmed on retention panoscreen, lot 43748. Rention immuadd, lot 5e5504 was evaluated for ability to enhance antibody reactivity and expected results were obtained. The returned sample was tested with panoscreen, lot 43748 using immuadd, lot 5e5004 as the potentiation with an incubation time of 10' at 37 c. No reactivity was observed. Sample was qns for further testing. No single test method will detect all antibodies. The patient sample contains weakly reactive antibodies that required enhanced incubation for detection.
Patient Sequence No: 1, Text Type: N, H10
[16254228]
Customer reports that a patient had a negative antibody screen in 2005 and was transfused with two units of red blood cells. The patient had a negative antibody screen the following month and was transfused with two units of red blood cells; subsequent testing showed the units to be k=and e=. One week later, the customer was performing correlation testing on randsom samples comparing a 10 minute incubation versus a 15 minute incubation using immuadd as the potentiator and panoscreen reagent red blood cells. One week earlier, sample was positive with the 15 minute incubation: anti-k and anti-e were identified. A positive direct antiglobulin was also detected and anti-k and anti-e were eluted from the patient's red blood cells.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2006-00136 |
| MDR Report Key | 767957 |
| Report Source | 06 |
| Date Received | 2006-10-04 |
| Date of Report | 2006-09-30 |
| Date Mfgr Received | 2005-12-13 |
| Date Added to Maude | 2006-10-11 |
| 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 | 0 |
| Manufacturer Contact | J WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMUADD |
| Generic Name | POTENTIATOR FOR IN VITRO DIAGNOSTIC USE |
| Product Code | LJO |
| Date Received | 2006-10-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 5E5504 |
| ID Number | * |
| Device Expiration Date | 2007-07-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 755839 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | * NORCROSS GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-04 |