MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-28 for ACCESS HFSH 33520 manufactured by Beckman Coulter, Inc..
[19930922]
Customer reported erroneous test results for access hypersensitive htsh (thyroid stimulating hormone), access total t4 (thyroxine), access hlh (luteinizing hormone) and access hfsh (follicle stimulating hormone) were obtained for one pt when using the unicel dxi 800 access immunoassay system. The erroneous high test results were reported out of the lab. Repeat analysis was performed with two alternate systems with correct test results obtained. Sample was analyzed at beckman coulter, inc the presence of a heterophile antibody was identified. There is no report of adverse event or serious injury related to this event. It is unk whether there was a change to pt mgmt. This is event 2 of 4 reported by the customer. An mdr was filed for each of the reagents demonstrating this issue.
Patient Sequence No: 1, Text Type: D, B5
[20279191]
Sample was analyzed at beckman coulter, inc. The presence of a heterophile antibody was identified. Product labeling states: "for assays employing antibodies, the possibility exists for interference by heterophile antibodies in the pt sample. Pts who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies, e. G. Hama, that interfere with immunoassays. Additionally, other heterophile antibodies such as human anti-goat antibodies may be present in pt samples. Such interfering antibodies may cause erroneous results. Carefully evaluate the results of pts suspected of having these antibodies. " root cause was determined to be the presence of a heterophile antibody in the pt's sample. This reportable event was identified during a retrospective review of product between jan 1, 2008 to october 23, 2010 of complaints for add'l reportable events. This event 2 of 4 reported by this customer. The related mdrs are: 2122870-2011-04873, 04913, 04914.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-04912 |
| MDR Report Key | 2320491 |
| Report Source | 05,06 |
| Date Received | 2011-10-28 |
| Date of Report | 2009-12-11 |
| Date of Event | 2009-11-03 |
| Date Mfgr Received | 2009-12-11 |
| Date Added to Maude | 2012-07-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 1000 LAKE HAZELTINE DR. |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS HFSH |
| Product Code | CGJ |
| Date Received | 2011-10-28 |
| Model Number | NA |
| Catalog Number | 33520 |
| Lot Number | 911588 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-28 |