MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-11-17 for CLINICAL CHEMISTRY ALBUMIN BCP 7D54-20 manufactured by Abbott Manufacturing, Inc..
[1305973]
The account stated that after calibrating the architect albumin bcp reagent with the new mcc calibrator lot 73223m200, there was a downward shift in the control values. This also occurred on the second architect analyzer. The account resolved the issue by increasing the calibration factors. There was no adverse impact to patient management reported. This is a user report.
Patient Sequence No: 1, Text Type: D, B5
[8364698]
(b)(4). Concomitant medical products: mcc calibrators list 1e65-04 lot 73223m200. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[8508868]
(b)(4). Clinical chemistry multiconstituent calibrator lot 73223m200 expiration date 6/30/2010. Albumin p reagent list 7d54-20, lot 78021hw00 manufactured date 6/30/2009. Expiration date 6/10/2010. Results of the supplemental investigation are as follows: the customers quality control (qc) values for albumin shifted low with first use of cc mcc, ln 1e65-04, lot 73223m200 while using clinical chemistry (cc) albumin bcp (albp) reagent lot 74003hw00 on two architect ci8200 systems. The customer was previously using cc mcc lot 63421m100 without any issue. For this investigation, cc albp reagent lots 74003hw00 and 76015hw00 were calibrated with cc mcc lots 63421m100, 73223m200, and 77118m200. Bio-rad unassayed lyphochek and assayed multiqual control mean values were compared to evaluate lot to lot variability between the calibrator and reagent lot combinations. Testing was performed on 3 architect systems. All control values were within the established ranges. In-house testing demonstrated the control values from cc albp obtained using cc mcc lot 73223m200 are lower than those generated with cc mcc lot 63421m100, however they are within established ranges. Since the controls are within the acceptable ranges, cc mcc (ln 1e65-04) lots 63421m100, 73223m200, and 77118m200 and cc albp reagent lots 74003hw00 and 76015hw00 are performing within specifications. No product deficiency could be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2009-00047 |
| MDR Report Key | 1530891 |
| Report Source | 01,05 |
| Date Received | 2009-11-17 |
| Date of Report | 2009-10-28 |
| Date Mfgr Received | 2009-12-29 |
| Device Manufacturer Date | 2008-10-06 |
| Date Added to Maude | 2010-03-29 |
| 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 | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT MANUFACTURING, INC. |
| Manufacturer Street | 820 MISSION ST. |
| Manufacturer City | SOUTH PASADENA CA 91030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY ALBUMIN BCP |
| Generic Name | FOR THE QUANTITATION OF ALBUMIN IN HUMAN SERUM OR PLASMA |
| Product Code | CJW |
| Date Received | 2009-11-17 |
| Catalog Number | 7D54-20 |
| Lot Number | 69053HW00 |
| Device Expiration Date | 2009-10-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US 91030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-17 |