MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,foreign,health professi report with the FDA on 2015-06-24 for ARCHITECT HE4 02P54-25 manufactured by Abbott Germany.
[20038829]
The customer stated that a falsely decreased architect he4 result of 33. 2 pmol/l was generated for a patient with a ca 125 result of 433. 1 u/ml and 3. 6% roma (risk of ovarian malignancy algorithm) on (b)(6) 2015. This testing was performed because a pelvic mass was found in the patient's sonography report. Surgery was performed on (b)(6) 2015 and the histopathological diagnosis revealed serious carcinoma of the ovary. The post-surgical roma was 49. 8%. A post-surgical he4 result was not provided. No adverse impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[20427770]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26124610]
This follow-up emdr is being submitted to correct the product code. Suspect medical device. The correct product code for this medical device, architect (b)(4). An evaluation is in process. A follow-up report will be submitted when the device evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[33001187]
Review of ticket trending and lot search data did not identify an increase in complaint activity related to discrepant patient results. Accuracy testing was completed using retained kits of reagent lot 42042m500. Acceptance criteria was met, which indicates acceptable product performance. A deficiency was not identified as accuracy testing shows that the assay performs per specification. No malfunction was identified since the issue involves one discreet patient and the sensitivity for stratifying patients with stage i-iv epithelial ovarian cancer into the high risk group is 93% at a specificity of 75%. Additionally, the limitations of the procedure and expected values section of the architect he4 package insert addresses the customer's issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002809144-2015-00043 |
| MDR Report Key | 4866822 |
| Report Source | 01,05,FOREIGN,HEALTH PROFESSI |
| Date Received | 2015-06-24 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-05-07 |
| Date Mfgr Received | 2015-08-14 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-07-20 |
| 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 | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT GERMANY |
| Manufacturer Street | MAX-PLANCK-RING 2 |
| Manufacturer City | WIESBADEN 65205 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65205 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT HE4 |
| Generic Name | HE4 |
| Product Code | OIU |
| Date Received | 2015-06-24 |
| Catalog Number | 02P54-25 |
| Lot Number | 42042M500 |
| Device Expiration Date | 2015-08-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT GERMANY |
| Manufacturer Address | MAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-24 |