MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-11-22 for IMX ANALYZER 8389-59 manufactured by Abbott Manufacturing, Inc..
[20934168]
A physician questioned an imx b-hcg result of 89,650 miu/ml on a pregnant female pt. The same sample was retested yielding an imx b-hc result of 192,180 miu/ul. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[21195875]
Due to the issue, the customer performed an imx dispense check on 11/03/2006 and an imx meia photo check on 11/06/2006. No hardware issues were found during the dispense and meia photo checks. The customer stated that the imx probe, multi-valve block, diluent and sample syringes were three years old. The customer stated that after changing the dispense components and recalibrating the assay, patient and control results were acceptable. Service history review for the time period of 11/01/2005 through 11/16/2006 indicates there have been no other complaints of inconsistent results on imx. The imx system operations manual (ln# 8376-07), section 10, troubleshooting, observed problems, meia test results and erratic meia test results provides a list of probable causes and corrective actions to resolve the issue. Dirty, damaged or incorrect positioning of the probe/electrode assembly and dirty or malfunctioning dispense components are listed as probable causes and replacing and/or recalibrating dispense components is provided as a corrective action. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2006-00093 |
| MDR Report Key | 791693 |
| Report Source | 05 |
| Date Received | 2006-11-22 |
| Date of Report | 2006-11-06 |
| Date of Event | 2006-10-23 |
| Date Mfgr Received | 2006-11-06 |
| Device Manufacturer Date | 2001-02-01 |
| Date Added to Maude | 2006-12-11 |
| 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 | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | LCI |
| Date Received | 2006-11-22 |
| Model Number | NA |
| Catalog Number | 8389-59 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 779332 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Baseline Brand Name | IMX ANALYZER(REFURB) |
| Baseline Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Baseline Model No | NA |
| Baseline Catalog No | 8389-59 |
| Baseline ID | NA |
| Baseline Device Family | IMX |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K864319 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-22 |