MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2007-11-16 for CLINICAL CHEMISTRY IRON 7D68-30 manufactured by Abbott Manufacturing, Inc..
[751670]
The customer states that results from the architect c8000 iron assay do not correlate with patient's clinical conditions and are being questioned by physicians. Also, the c8000 results do not correlate with another manufacturer's method. Patient #5 generated an architect c8000 iron result of 2. 89 umol/l that tested at 15. 1 umol/l by the other manufacturer's method. Controls have remained within specifications. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8009717]
An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[8178216]
(b)(4). The customer was concerned with lower than expected results using the clinical chemistry iron assay, ln 7d68-30, lot # 52002hw00 on the architect c8000 analyzer. Patient results did not match the clinical state of the patients and did not correlate with another manufacturer's iron assay. The investigation was re-opened to allow for additional electrophoresis testing to verify sample type. The protein electrophoresis revealed atypical bands in the slow-beta region of the gel. For two of the samples (0071 and 0544) the bands are of moderate size and intensity. For the other two samples (0518 and 0538), the bands are slightly more anodal and of reduced intensity. These bands could be fibrinogen, monoclonal gammopathies, c3 degradation (conversion) or a combination of all three. Immunofixation results added clarity to the interpretation. There is no evidence of a monogammopathy in the four samples when tested with anti-human igg, iga, igm, kappa (f&b), or lambda (f&b). Specimens 0071 and 0544 are clearly plasma or serum that were not fully clotted as evidenced by the strong reactivity to ant-human fibrinogen. Specimens 0518 and 0538 showed no reactivity to ig's or fibrinogen when the samples were assayed according to a standard protocol or when the samples were treated with dithiothreitol (dtt) a reducing agent. Thus, the bands on protein electrophoresis are not monoclonal proteins or immune complexes, and may simply be c3 that is undergoing degradation due to storage. The c3 band is somewhat reduced and the band rather diffuse, which would be consistent with degradation. Based on the information obtained during this investigation, no deficiencies have been found for clinical chemistry iron. Electrophoresis results indicate two of the samples are likely plasma, while the other two samples exhibit properties closer to serum that has degraded. The clinical chemistry iron package insert , ln 7d68 (b)(4), dated (b)(6) 2003, specifies that serum is the acceptable specimen type for this assay. There is no plasma claim with clinical chemistry iron (ln 7d68) using the architect system. Results of this investigation suggest the issue is isolated to certain patient samples. No product deficiency can be determined with the clinical chemistry iron reagent. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00244 |
| MDR Report Key | 950645 |
| Report Source | 01 |
| Date Received | 2007-11-16 |
| Date of Report | 2007-10-31 |
| Date Mfgr Received | 2009-03-27 |
| Device Manufacturer Date | 2007-04-20 |
| Date Added to Maude | 2009-03-31 |
| 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 | DR. 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 IRON |
| Generic Name | FOR THE QUANTITATION OF IRON IN HUMAN SERUM |
| Product Code | CFM |
| Date Received | 2007-11-16 |
| Model Number | NA |
| Catalog Number | 7D68-30 |
| Lot Number | 52002HW00 |
| ID Number | NA |
| Device Expiration Date | 2008-03-29 |
| Operator | OTHER |
| 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 | 2007-11-16 |