MAUDE Adverse Event Report: BECKMAN COULTER ACCESS PROGESTERONE REAGENT; RADIOIMMUNOASSAY, PROGESTERONE

Catalog Number	33550
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).
Event or Problem Description
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.

• Brand Name: ACCESS PROGESTERONE REAGENT
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 5876046
• Report Number: 2122870-2016-00395
• Device Sequence Number: 14556771
• Product Code: JLS
• Combination Product (Y/N): N
• PMA/510(K) Number: 955769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Type of Report: Initial
• Report Date (Section B): 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 33550
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2016
• Initial Report FDA Received Date: 08/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other