MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-04-30 for GAMMA N-HANCE manufactured by Immucor.
[1301337]
Customer reported a patient sample with multiple antibodies was nonreactive when testing was performed using gamma n-hance. The patient has a history of anti-k, anti-c, anti-e and a warm autoantibody.
Patient Sequence No: 1, Text Type: D, B5
[8473559]
Review of antibody screen with n-hance shows that all cells resulted negative. Tested a sample with known igg antibody (anti-fya) using retention n-hance, lot 335007 and without n-hance as the potentiator, using retention panoscreen i, ii and iii. The antibody was enhanced from 2+ to 3+ reactivity with the use of retention n-hance as the potentiator at the indirect antiglobulin test. Retention products performed as expected. Tested a sample with known igg antibody (anti-fya) using returned n-hance, lot 335007 and without n-hance as the potentiator on retention panoscreen i, ii and iii. The antibody was enhanced from 2+ to 3+ reactivity with the use of returned n-hance as the potentiator at the indirect antiglobulin test. Returned products performed as expected. The submitted patient sample was tested with retention panoscreen i, ii and iii using three sets of testing parameters: set a -without n-hance; set b - with retention n-hance; set c - with returned h-hance. The results were as follows: set a - the sample exhibited no reactivity macro/micro at the indirect antiglobulin test (iat) set b - the sample exhibited very weak to microscopic reactivity with cell i, e-,c-, k- reagent red cells only. No reactivity was observed with cell ii and iii. Set c - the same reactivity was observed as set b. The returned sample was tested with retention panoscreen i, ii and iii using retention peg. The sample exhibited weak reactivity with cell i and ii and 1+ reactivity with cell iii. The sample was tested with retention capture-r ready screen 3 , lot r084 on our in-house echo. The sample exhibited 4+ reactivity with all three reagent red cells. It appears that based on the above results, the antibody that is very weakly detected with returned and retention n-hance is the warm auto antibody. Previous anti-e, -c and -k were not detected. The warm auto antibody was also detected weakly using peg and in capture assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2010-00104 |
| MDR Report Key | 1670620 |
| Report Source | 05,06 |
| Date Received | 2010-04-30 |
| Date of Report | 2010-04-29 |
| Date of Event | 2010-04-02 |
| Date Mfgr Received | 2010-04-02 |
| Date Added to Maude | 2010-11-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. J. WEBBER |
| Manufacturer Street | IMMUCOR 3150 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30091 |
| Manufacturer Country | US |
| Manufacturer Postal | 30091 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30091 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30091 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMMA N-HANCE |
| Generic Name | POTENTIATING MEDIA FOR IN-VITRO DIAGNOSTIC USE |
| Product Code | KSG |
| Date Received | 2010-04-30 |
| Returned To Mfg | 2010-04-02 |
| Lot Number | 335007 |
| Device Expiration Date | 2012-05-29 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30071 US 30071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-30 |