MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-28 for CAPTURE-CMV INDICATOR RED CELLS 0066238 manufactured by Immucor, Inc..
[2073196]
A customer reported donors samples that were previously reported out as cmv negative are now displaying positive reactivity on the galileo. The customer stated no repeat testing on the instrument was done or will be performed. The customer stated no adverse event occurred as a result of the unexpected reactions.
Patient Sequence No: 1, Text Type: D, B5
[9168824]
Performed a cmv assay on 24 known negative cmv donors on the galileo using one full plate of retention capture-cmv, lot (b)(4) and capture-cmv indicator red cells, lot (b)(4). Controls performed as expected and 22 of the donors tested negative as expected. Two of the donors repeatedly tested positive (x3). Those donors tested cmv negative using capture-cmv indicator red cells, (b)(4). Retention products did not perform as expected. Performed a cmv assay on 6 known cmv negative in house donors on the galileo using retention capture-cmv, lot (b)(4) and the customers returned vials of capture-cmv indicator red cells, lot (b)(4). Controls performed as expected and all in house donors tested negative as expected with the first vial tested. One of the 6 donors tested positive when using the second vial. Returned products did not perform as expected. Performed a cmv assay on the customers returned samples on the galileo using retention capture-cmv, lot c087 and capture-cmv indicator red cells, lot (b)(4). Controls performed as expected and only sample (b)(6) tested negative. All four samples tested positive. A service call was made. Adjustments made to the instrument as needed. Tested cmv negative patient samples, 7/9 samples came out weak positive. Instrument is working within specifications mechanically. Cannot rule out that the cmv indicator cells may have been compromised.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2011-00078 |
| MDR Report Key | 2143271 |
| Report Source | 05,06 |
| Date Received | 2011-06-28 |
| Date of Report | 2011-06-24 |
| Date of Event | 2011-05-31 |
| Date Mfgr Received | 2011-05-31 |
| Date Added to Maude | 2012-04-26 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR SCOTT WEBBER |
| 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 30091562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30091 5625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-CMV INDICATOR RED CELLS |
| Generic Name | ANTI-IGG AND ANTI-IGM COATED RED CELLS INTENDED FOR USE IN CAPTURE-CMV ASSAYS |
| Product Code | LJO |
| Date Received | 2011-06-28 |
| Catalog Number | 0066238 |
| Lot Number | 228149 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30091562 US 30091 5625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-28 |