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

Catalog Number 07027737190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).(b)(6).This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys prolactin assay results with 23 patient samples on a 8000 e 801 module, serial number (b)(4).Refer to attachment "(b)(6)" for patient results.The roche results were questioned as they were incompatible with the patients' clinical picture and repeat testing by the siemens centaur method was performed.

Manufacturer Narrative

Calibration and qc were within specifications.The customer correctly pretreated the samples with peg (polyethylene glycol) prior to testing.Testing results: (listed as: patient id: prl ii+peg (ng/ml), prl ii/c, peg/c).2: 33, 149%, 112%.3: 32, 143%,119%.4: 37.8, 172%, 147%.5: 28.2, 136%, 107%.6: 33.4, 139%, 121%.7: 26.6, 150%, 121%.8: 38.4, 141%, 139%.9: 24.8, 152%, 119%.14: 19.76, 132%, 101%.15: 22.4, 133%, 114%.17: 19.36, 154%, 127%.18: 29.4, 178%, 154%.19: 22, 131%, 100%.20: 31.8, 147%, 123%.21: 27, 131%, 76%.22: 40.6, 139%, 96%.23: 18.3, 146%, 90%.24: 27.2, 173%, 145%.26: 57.4, 144%, 121%.27: 25.2, 141%, 129%.29: 17.48, 144%, 107%.31: 19.32, 151%, 131%.32: 15.14, 172%, 123%.The investigation found that the samples are suspicious of containing high amounts of macro prolactin, for which the elecsys prl ii assay is more sensitive than the centaur/seimens platform.The customer pre-selected special patient samples and compared those to a competitor assay.This is suggested by high frequency of > reference range samples with low post-peg prl ii recovery the investigation concluded the measured values are correct.The investigation did not identify a product problem.

• Brand Name: ELECSYS PROLACTIN ASSAY
• Type of Device: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11388436
• MDR Text Key: 254710418
• Report Number: 1823260-2021-00602
• Device Sequence Number: 1
• Product Code: CFT
• Combination Product (y/n): N
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 07027737190
• Device Lot Number: 48264802
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1