MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2008-09-11 for CLINICAL CHEMISTRY IRON 7D68-30 manufactured by Abbott Manufacturing, Inc..
[921835]
The customer states that a young female patient taking estrogen generated an architect c8000 iron assay result of less than 6. 0 ug/dl. The result was reported from the lab. The sample retested with the same result. The sample was then tested on a competitor's platform and generated a result of 60 ug/dl. Controls have remained within specifications. There is no further information provided as to any impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8238897]
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
[8252895]
(b)(4). Clinical chemistry iron for the quantitation of iron in human serum. The customer lost the patient samples in question and therefore, no samples were available for this investigation from the customer site. Lot release data contained in the certificate of analysis for iron reagent lot 60030hw00 did not indicate any issue with performance. Due to lack of patient samples, testing was not performed to either confirm or refute the alleged complaint issue. No product deficiency can be determined with the clinical chemistry iron reagent. College of american pathologists participant summary excerpts, from the 2007 chemistry survey cz-c, show the various methodologies utilized by the olympus instruments. Clinical chemistry iron uses a different methodology which is ferene without ppr and produced lower results than the methodologies utilized by the olympus instruments. The olympus reagent lists serum and heparinized plasma as suitable specimens while clinical chemistry iron lists only serum as the required specimen type. Results seen by the customer are consistent with plasma samples rather than serum. The specimens may have been drawn from a heparin line that was insufficiently cleared of heparin or the patient may be on anticoagulant therapy. A review of complaints found no issues requiring further investigation. The clinical chemistry iron package insert, commodity # (b)(4), (b)(6) 2008 contains adequate information to address this customer's issue. Serum is listed as the only required specimen type. The investigation demonstrated that the clinical chemistry iron assay is performing within its intended use, label claims and specifications. No deficiency related to the performance of the device was identified. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2008-00182 |
| MDR Report Key | 1159468 |
| Report Source | 01 |
| Date Received | 2008-09-11 |
| Date of Report | 2008-09-05 |
| Date of Event | 2008-09-05 |
| Date Mfgr Received | 2009-03-16 |
| Device Manufacturer Date | 2008-01-11 |
| Date Added to Maude | 2009-03-16 |
| 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 | 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 | 2008-09-11 |
| Model Number | NA |
| Catalog Number | 7D68-30 |
| Lot Number | 60030HW00 |
| ID Number | NA |
| Device Expiration Date | 2008-10-30 |
| 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 | 2008-09-11 |