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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

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HOLOGIC, INC THINPREP 5000 PROCESSOR Back to Search Results
Device Problem Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
Customer in (b)(6) reported their thinprep 5000 processor with autoloader printed a wrong vial id onto a slide.The instrument did not present any error to the operator.The customer sent pictures to (b)(4) for investigation and it was noted that the customer is using 1d barcodes on both slide and vial.It was confirmed that the sample was reprocessed without error on the same t5 autoloader.No patient recall or diagnosis delay noted.Fse confirmed but unable to reproduce error.Found the following to be the most likely cause of the error.Barcode scanner, scanner upgraded as part of (b)(4), documented on (b)(4).Processed samples to confirm operation.Instrument operational.Although no patients needed to be recalled as a result of this incident this is a reportable event since the instrument did not perform as intended.
 
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Brand Name
THINPREP 5000 PROCESSOR
Type of Device
THINPREP 5000 PROCESSOR
Manufacturer (Section D)
HOLOGIC, INC
250 campus drive
marlborough MA 01752
Manufacturer Contact
sidra piracha
250 campus drive
marlborough, MA 01752
5082638884
MDR Report Key5632631
MDR Text Key45097741
Report Number1222780-2016-00110
Device Sequence Number1
Product Code MKQ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 05/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received04/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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