MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-10 for CAPTURE-CMV 0066206 manufactured by Immucor, Inc..
[45138867]
No electronic connection method for manual capture workstation was available, for use by immucor technical support. The blood sample was from a donor, and further testing was not possible because there was not enough sample volume remaining. No extra sample vol to continue testing.
Patient Sequence No: 1, Text Type: N, H10
[45138868]
On (b)(6) 2016, a customer site reported an unexpectedly positive cmv test when using capture-cmv on a manual capture workstation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2016-00105 |
| MDR Report Key | 5643983 |
| Date Received | 2016-05-10 |
| Date of Report | 2016-05-10 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-04-15 |
| Date Added to Maude | 2016-05-10 |
| 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 | CAPTURE-CMV |
| Generic Name | SOLID PHASE SYSTEM FOR DETECTION OF IGG AND IGM ANTIBODIES TO CYTOMEGALOVIRUS |
| Product Code | LJO |
| Date Received | 2016-05-10 |
| Catalog Number | 0066206 |
| Lot Number | C121 |
| Device Expiration Date | 2016-05-18 |
| 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 | 2016-05-10 |