MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-09-01 for ACCESS PROGESTERONE REAGENT 33550 manufactured by Beckman Coulter.
[53701705]
The customer did not supply patient demographics such as age, date of birth or weight. There is no evidence that the access progesterone reagent was returned for evaluation. A beckman coulter (bec) field service engineer (fse) was dispatched to the customer's site. No hardware malfunctions were reported that may have caused, or contributed to this event. There was no evidence to reasonably suggest an analyzer malfunction or reagent/calibrator performance issue. In conclusion, an assignable cause for this event cannot be confirmed with the available information.
Patient Sequence No: 1, Text Type: N, H10
[53701706]
On (b)(6) 2016, the customer reported obtaining a low progesterone (access progesterone) result in association with their access 2 immunoassay system (serial number (b)(4)). The initial access progesterone recovery was below the expected result. This result was released from the laboratory. There was a report of a change to patient treatment which occurred in association with the low access progesterone result obtained on (b)(6) 2016. The patient was administered progesterone medication. No additional change in patient treatment or injury was reported. The same patient's sample was analyzed on an alternate analyzer, unicel dxi 800 access immunoassay system (serial number unknown) and recovered with similar results, below the expected reference range for this patient. A second sample was obtained from the patient on (b)(6) 2016 and was analyzed on a roche instrument and recovered with higher results, within the customer's expectations. The customer did not report issues with other assays. Information on quality control was not provided. No hardware errors, flags or other assay issues were reported in conjunction with this incident. The customer did not supply any information regarding the patient's sample collection and/or the speed, time, and temperature at which the sample was centrifuged. A beckman coulter (bec) field service engineer(fse) was dispatched to evaluate the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2016-00430 |
| MDR Report Key | 5921117 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-04 |
| Date of Event | 2016-07-18 |
| Date Mfgr Received | 2016-08-04 |
| Device Manufacturer Date | 2016-02-20 |
| Date Added to Maude | 2016-09-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGELA KILIAN |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681330 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS PROGESTERONE REAGENT |
| Generic Name | RADIOIMMUNOASSAY, PROGESTERONE |
| Product Code | JLS |
| Date Received | 2016-09-01 |
| Model Number | NA |
| Catalog Number | 33550 |
| Lot Number | 536965 |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-01 |