MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-07 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[638142]
A customer contacted beckman coulter inc. (bci) regarding erroneously low prostate specific antigen (psa) results from two (2) different patient samples that were generated by the access 2 instrument. The initial psa results were: 3. 65ng/ml for patient a and 1. 85ng/ml for patient b. The results were not reported out of the lab. The original samples were retested for psa and the repeated results were higher for both patients: psa results for patient a were: 5. 37ng/ml and 5. 61ng/ml. Psa result for patient b was 5. 13ng/ml. Per customer, the higher psa results for patient a were confirmed at a different lab. Additionally, customer provided a previous psa result of 9. 11ng/ml which was obtained for this patient a few months earlier. The customer did not receive any report of patient injury requiring medical intervention, or change to patient treatment attributed or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
[7976546]
Qc was within specifications before the event. Qc performed in 2007, after maintenance, was within specifications for levels i and ii. Level iii was out of specifications high initially and upon repeat. The samples are collected at offsite physician's offices, in plastic, bd, serum separator tubes (sst). A field service engineer (fse) was dispatched to the customer's lab: while on-site, the fse observed in-coming specimens and questioned their integrity. The specimens were centrifuged at 1,000g. The fse recommended increasing centrifuge speed to 1,300g. The fse printed and discussed pre-analytical sample handling data with the customer. The fse replaced upper and lower precision pump seals. The fse installed new transducer and performed transducer adjustment procedure. The fse performed diagnostic testing with passing results. The fse verified the instrument per established rocedures. In a follow-up with the customer five days later, they had not had any further issues with psa results. The customer stated they were unaware that the collection tubes were changed to plastic tubes from glass tubes. They also stated, they were unaware these tubes needed to be inverted after blood collection. A pre-analytical sample handling packet, and a cd presentation was sent to customer in assisting the training of staff on proper sample handling. A clear root cause has not been determined for this event. A malfunction will be assumed for the purpose of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2007-00107 |
| MDR Report Key | 860942 |
| Report Source | 05 |
| Date Received | 2007-05-07 |
| Date of Report | 2007-05-07 |
| Date of Event | 2007-04-18 |
| Date Mfgr Received | 2007-04-18 |
| Device Manufacturer Date | 2003-10-01 |
| Date Added to Maude | 2007-06-06 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | NORA ZEROUNIAN, MANAGER |
| Manufacturer Street | 200 S. KRAEMER BLVD PO BOX 8000, MAIL STOP: W-110 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS 2 IMMUNOASSAY SYSTEM |
| Generic Name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Product Code | NAF |
| Date Received | 2007-05-07 |
| Model Number | ACCESS 2 IMMUNOASSAY SYSTEM |
| Catalog Number | 81600N |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 844081 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-07 |