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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT4, FREE THYROXINE; RADIOIMMUNOASSAY, FREE THYROXINE

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ROCHE DIAGNOSTICS FT4, FREE THYROXINE; RADIOIMMUNOASSAY, FREE THYROXINE Back to Search Results
Catalog Number 06437281190
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).(b)(4).
 
Event Description
The customer stated that they received questionable results for a total of 245 patient samples tested on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170).Of the 245 patient samples, 89 had erroneous test results.The erroneous results were reported outside of the laboratory to the doctor.The affected assays include: the elecsys afp assay (afp), the elecsys ca 19-9 immunoassay (ca 19-9), the elecsys cea assay (cea), the elecsys total psa immunoassay (psa), elecsys ft3 iii (free-t3), the elecsys ft4 ii assay (free-t4), and the elecsys tsh assay (tsh).Please refer to the medwatches with the following a1.Patient identifiers for information related to each affected assay: (b)(6) = tsh (b)(6) = free-t3 (b)(6) = free-t4 (b)(6) = afp (b)(6) = ca 19-9 (b)(6) = cea (b)(6) = psa.Please refer to the attachment for all patient data.The samples were initially tested on the customer's e170 analyzer (named elecsys on attachment).The elecsys values highlighted in orange are erroneous.The samples were repeated using the abbott architect and wako accuraseed methods.Sample 31 was provided for investigation where it was tested for tsh, free-t3, and free-t4 on a cobas 8000 e 801 module - e801 (see bottom of attachment).No adverse events were alleged to have occurred with the patients.The serial number of the customer's e170 analyzer is (b)(4).The serial number of the e801 analyzer used for investigation was (b)(4).Ft4 reagent lot number 288197, with an expiration date of december 2018 was used on this analyzer.
 
Manufacturer Narrative
The reference ranges for the wako accuraseed methods are as follows: tsh = 0.5 - 4.8 uiu/ml, ft4 = 0.87 - 1.72 ng/dl, ft3 = 2.39 - 3.86 pg/ml.
 
Manufacturer Narrative
Differences in results and reference ranges from thyroid assays by different manufactures, in this case abbott, can vary due to differences in the types of antibodies used, setups of the assays, and standardization methodologies.The investigation could not determine a definitive root cause.
 
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Brand Name
FT4, FREE THYROXINE
Type of Device
RADIOIMMUNOASSAY, FREE THYROXINE
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7638724
MDR Text Key112573488
Report Number1823260-2018-02042
Device Sequence Number1
Product Code CEC
Combination Product (y/n)N
PMA/PMN Number
K961489
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 08/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number06437281190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age87 YR
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