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 2016-08-15 for ACCESS PROGESTERONE REAGENT 33550 manufactured by Beckman Coulter.
[52106180]
The customer did not supply patient demographics such as age, date of birth or weight. The customer was using two access progesterone reagent lots at the time of the event, but did not supply which lot number was in use when the lower access progesterone result was obtained. Lot 528249, manufactured september 11, 2015, expiration date of february 28, 2017. Lot 534469 manufactured january 6, 2016, expiration date of june 30, 2016. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[52106181]
The customer reported obtaining non-reproducible low progesterone (access progesterone) results in association with the unicel dxi 800 access immunoassay system serial number (b)(4) for one (1) patient. The initial patient sample was analyzed on (b)(6) 2016 and recovered within expectations. On (b)(6) 2016, a second sample was collected from the same patient and recovered lower, below expectations. A third sample was collected from the same patient on (b)(6) 2016 and a higher result was obtained. All analyses were performed on the same unicel dxi 800 access immunoassay system serial number (b)(4) and the results were released from the laboratory. There was a report of a change to patient care or treatment which occurred in association with the non-reproducibly low access progesterone result obtained on (b)(6) 2016. The patient was administered progesterone medication. This medication was discontinued after the customer obtained higher progesterone results on the same unicel dxi 800 access immunoassay system and an abbott instrument. No additional change in patient treatment or injury was reported. The customer did not report issues with other assays. Quality control was within specifications at the time of this event. No hardware errors, flags or other assay issues were reported in conjunction with this event. The patient's sample was collected in a serum tube. The customer did not supply any additional 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 | 2122870-2016-00395 |
| MDR Report Key | 5876046 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-15 |
| Date of Report | 2016-08-04 |
| Date of Event | 2016-04-19 |
| Date Mfgr Received | 2016-08-04 |
| Date Added to Maude | 2016-08-15 |
| 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 | 2016-08-15 |
| Model Number | NA |
| Catalog Number | 33550 |
| 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 | 2016-08-15 |