MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-07 for CAPTURE-S manufactured by Immucor, Inc..
[897666]
Customer reported unexpected negative reactions with capture-s assay on the galileo during validation testing. The 189 known reactive and non reactive samples were run on the galileo. Twenty five out of 189 samples were tested by other methods and were reactive. The samples were initially tested using the rpr, trep-check or trinity captia methods, then retested on the galileo. Customer later reported more unexpected negative reactions with capture-s assay on galileo.
Patient Sequence No: 1, Text Type: D, B5
[8018753]
Testing was performed on an in-house galileo with retention capture-s, lot s106 and capture-s indicator red cells, lot 229040 no unexpected nonreactivity was observed. Testing was performed on an in-house galileo with customer's returned patients' samples. Using retention capture-s, lot s105 and capture-s indicator red cells, lot 229040. 4 samples were qns for galileo testing; 2 samples exhibited positive reactivity. All other samples tested were nonreactive. Testing was performed on an in-house galileo with retention capture-s, lot s103 and retention capture-s indicator red cells, lot 229045 using customer's patients' samples. All customer's patients' samples were nonreactive. Buttons appeared negative (slightly fuzzy) visually. Performed rpr card tests on customer's samples. Six of 18 samples were nonreactive. Manual testing was performed with retention capture-s, lot s104 and retention capture-s indicator red cells, lot 229045 using customer's patients' samples. Approxiamtely 10 of 17 samples tested were reactive.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2008-00236 |
| MDR Report Key | 1068282 |
| Report Source | 05,06 |
| Date Received | 2008-07-07 |
| Date of Report | 2008-07-02 |
| Date of Event | 2008-06-13 |
| Date Mfgr Received | 2008-06-13 |
| Date Added to Maude | 2008-07-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. J. SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-S |
| Generic Name | NONTREPONEMAL SYPHILIS SCREENING TEST |
| Product Code | GMQ |
| Date Received | 2008-07-07 |
| Lot Number | 299033 |
| Device Expiration Date | 2007-02-09 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1035364 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30071 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-07 |