MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-02-14 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[100282069]
The full number for the product in question is bk020053 ((b)(6) 2003). Immucor technical support used a remote electronic connection method on (b)(6) 2018 to assess the instrument test well image in question. Immucor did a dhr review on 26jan2018, after the product had already expired, which showed that all specifications had been met before the product was released to market. (b)(4). This report is a correction report for (b)(4) because the original record had a set of erroneous hospital demographic information for the hospital. The erroneous information in the original (b)(4) was from a hospital in (b)(6). The corrected and accurate demographic information in this (b)(4) report is for the hospital in flushing ny.
Patient Sequence No: 1, Text Type: N, H10
[100282070]
On 19jan "2017", a customer site reported an unexpected negative antibody screen when using capture-r ready indicator red cells on a galileo echo instrument, when tested on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00043 |
| MDR Report Key | 7270265 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2018-02-14 |
| 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 | 3 |
| Brand Name | CAPTURE-R READY INDICATOR RED CELLS |
| Generic Name | ANTIGLOBULIN COATED RED CELLS |
| Product Code | KSF |
| Date Received | 2018-02-14 |
| Catalog Number | 0006428 |
| Lot Number | 221996 |
| Device Expiration Date | 2018-01-18 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2018-02-14 |