MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-01-13 for ARCHITECT I2000SR ANALYZER 03M74-02 manufactured by Abbott Manufacturing Inc.
[64737320]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Patient information, patient identifier - multiple are sid (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[64737321]
The customer stated that the architect analyzer generated falsely elevated afp results on two patients. The results provided were: sid (b)(6) on (b)(6) 2016 afp = 8. 23 / 3. 21; (b)(6) 2016 sid (b)(6) afp = 11. 88 / 2. 2ng/ml. There was no additional patient information provided. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[71871521]
Evaluation of the customer issue included a review of: the complaint text, service history, trend reports, complaint searches, and product labeling. There was no patient sample provided to assist in the investigation. The complaint text indicated field service resolved the issue by cleaning a clogged wash zone 2 manifold (part number 7-96176-05) on (b)(6) 2016. The customer notified service of the discrepant results after the completion of the service visit. A review of the analyzer service history identified service tickets opened around the time of the results issue: (b)(6) 2016 concerns regarding wash aspirate monitoring alerts for wash zone 2, probe 2 and the temperature tubing/sensor was replaced; on (b)(6) 2016 error code 3350 [unable to process test, aspiration error for (sample pipettor) at (rv24)] and the sample probe was adjusted by the customer; lastly, on (b)(6) 2016 ec 3350 [unable to process test, aspiration error for (r2 pipettor) at (reagent carousel)] and the fsr replaced a syringe assembly. There have been no subsequent contacts from the customer regarding discrepant results since the wz manifold was cleaned and the adjustment/replacement of additional service parts identified above was performed. The architect system operations manual provides information including: troubleshooting and corrective actions to resolve ec 3350; and for observed problems / erratic results. The architect afp package insert provides information for assay processing, limitations of the procedure, performance characteristics and interpretation of results. A search for similar complaints identified no adverse trend of wz manifold in the past 12 months. A historic review of the architect i2000sr revealed no systemic issues or trends associated with erratic results. Based on the investigation performed, a malfunction was identified, however, no systemic issue or product deficiency of the instrument or part was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00008 |
| MDR Report Key | 6248983 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-01-13 |
| Date of Report | 2017-03-29 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2017-03-28 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2017-01-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | CDZ |
| Date Received | 2017-01-13 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Brand Name | ARCHITECT I2000SR ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-01-13 |
| Catalog Number | 03M74-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-13 |