MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-11-03 for IMX ANALYZER 8389-59 manufactured by Abbott Manufacturing, Inc..
[548622]
The customer reported an imx bhcg result of 8078 mlu/ml on a female patient. The sample was retested four days later and the imx bhcg result was 22128 mly/ml. The sample was sent to a reference laboratory for testing which confirmed the repeat imx result. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[7804851]
To troubleshoot the issue, the customer performed a buffer run and identified splashing at the predilution well. The customer decided to change the probe and perform boom calibration with level sense and repeat the buffer run. After replacing the probe, the customer performed a buffer run and was unable to get a passing level sense. Abbott field service was then requested to resolve the issue. Abbott field service replaced the multivalve block and the sample and diluent syringes with interconnect tubings. Upon follow-up by abbott, the customer stated that the level sense was still not resolved and abbott field service was dispatched again to evaluate the imx analyzer. No problem was observed. Service was unable to verify the issue. To optimize the system, the abbott field service representative lubricated the boom shafts and adjusted the boom levels. A dispense check, meia photocheck, and precision run on the b-hcg low control passed. The customer stated that the analyzer is now running to the laboratory's expectation. Since multiple components were replaced and maintenance procedures were performed, the exact cause of the erratic results could not be determined. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2006-00086 |
| MDR Report Key | 786187 |
| Report Source | 05 |
| Date Received | 2006-11-03 |
| Date of Report | 2006-10-11 |
| Date of Event | 2006-10-05 |
| Date Mfgr Received | 2006-10-11 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 2006-11-27 |
| 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 | 2006-11-03 |
| 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 | 773986 |
| 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 | 2006-11-03 |