MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-15 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[17096823]
Customer reported erroneous test results for vitamin b12 were obtained while using an access 2 immunoassay sys. Reported imprecision with the vitamin b12 assay occurring with the last tests of the reagent pack. It is unk if erroneous results were reported out of the lab. Affect to pt treatment is unk. No reports of death or serious injury as a result of this event. This event represents event 13 of 17 events reported by this customer for 13 pt samples.
Patient Sequence No: 1, Text Type: D, B5
[17319471]
The customer runs 3 levels of qc at the beginning of every reagent pack and it is within the customer's specs. Customer states the 48th through the 50th test of each reagent pack is erroneously high. Issue is isolated to only this assay. The field svc engineer performed a sys check which passed. The instrument was up to date with all maintenance. The investigation did not confirm customer's statement that all erroneous results were performed at the end of the reagent package. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 and (b)(4) 2010 of complaints for add'l reportable events. This mdr represents event 13 of 17 reported by this customer. The 17 related mdrs that have been reported are: mdr 2122870-2011-01253, 02205, 02206, 02207, 02208, 02209, 02210, 02211, 02212, 02213, 02214, 02215, 02216, 02218, 02219, 02220, 02221.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-02217 |
| MDR Report Key | 2169949 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-15 |
| Date of Report | 2009-01-06 |
| Date of Event | 2008-12-30 |
| Date Mfgr Received | 2009-01-06 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2012-05-25 |
| 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 Phone | 7149613634 |
| 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 2 IMMUNOASSAY SYSTEM |
| Product Code | CGN |
| Date Received | 2011-07-15 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-07-15 |