MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROLACTIN ASSAY; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number	07027737190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter complained of discrepant results for 2 samples from 1 patient tested for elecsys prolactin assay (prolactin) on a cobas e801 module.On (b)(6) 2021 the initial result from the e801 module was 3045 miu/l.This result was reported outside of the laboratory.The sample from (b)(6) 2021 was tested by the siemens method with a result of 2040.14 miu/l and by the beckman method with a result of 1735.43 miu/l.The customer treated the sample from (b)(6) 2021 with polyethylene glycol (peg) and the result from the e801 module was 2334 miu/l.On (b)(6) 2021 a new sample was obtained and the result from the e801 module was 232 miu/l.This result was reported outside of the laboratory.The sample from (b)(6) 2021 was tested by the siemens method with a result of 144.22 miu/l and by the beckman method with a result of 150.3 miu/l.The sample from (b)(6) 2021 was not treated and tested using peg.The e801 module serial number was (b)(4).
Additional Manufacturer Narrative
Calibration and qc were acceptable.No instrument issues were identified.Individual samples from this patient may show different results between different prolactin methods.Product labeling states: "in case of implausible high prolactin values a precipitation by polyethylene glycol (peg) is recommended in order to estimate the amount of the biological active monomeric prolactin." the difference between the different methods was acceptable for the customer's peg treated samples.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The initial report stated: "the initial reporter complained of discrepant results for 2 samples from 1 patient tested for elecsys prolactin assay (prolactin) on a cobas e801 module.On (b)(6)2021 the initial result from the e801 module was 3045 miu/l.This result was reported outside of the laboratory.The sample from (b)(6)2021 was tested by the siemens method with a result of 2040.14 miu/l and by the beckman method with a result of 1735.43 miu/l.The customer treated the sample from (b)(6)2021 with polyethylene glycol (peg) and the result from the e801 module was 2334 miu/l.On (b)(6)2021 a new sample was obtained and the result from the e801 module was 232 miu/l.This result was reported outside of the laboratory.The sample from (b)(6)2021 was tested by the siemens method with a result of 144.22 miu/l and by the beckman method with a result of 150.3 miu/l.The sample from (b)(6)2021 was not treated and tested using peg." updated information was received that indicates the correct sequence of events is: the initial reporter complained of discrepant results for 2 samples from 1 patient tested for elecsys prolactin assay (prolactin) on a cobas e801 module.On (b)(6)2021 the initial result from the e801 module was 3045 miu/l.This result was reported outside of the laboratory.On (b)(6)2021 the sample was repeated on the e801 module with a result of 2616 miu/ml.The sample from (b)(6)2021 was tested by the siemens method with a result of 2040.14 miu/l and by the beckman method with a result of 1735.43 miu/l.On (b)(6)2021 a new sample was obtained and the result from the e801 module was 232 miu/l.This result was reported outside of the laboratory.The sample from (b)(6)2021 was tested by the siemens method with a result of 144.22 miu/l and by the beckman method with a result of 150.3 miu/l.On(b)(6)2021 the customer pulled the sample from (b)(6)2021 and treated it with polyethylene glycol (peg) and the result from the e801 module was 2334 miu/l.The sample from (b)(6)2021 was not treated and tested using peg.".

• Brand Name: ELECSYS PROLACTIN ASSAY
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12862090
• Report Number: 1823260-2021-03454
• Device Sequence Number: 4080569
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K964748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 07027737190
• Device Lot Number: 52654801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/29/2021; 12/13/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/15/2021; 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEPARIN; PROGYNOVA
• Patient Age: 39 YR
• Patient Sex: Female