MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC. GENPOINT TYRAMIDE SIGNAL AMPLIFICATION SYSTEM FOR BIOTINYLATED PROBES; GENPOINT CATALYZED SIGNAL AMPLIFICATION SYSTEM

Catalog Number K0620

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 10/20/2015

Event Type  No Answer Provided  

Event Description

Complaint received from a customer in (b)(6) regarding unexpected staining background with use genpoint catalyzed signal amplication system for in situ hybridization.An investigation of the complaint is ongoing.

Manufacturer Narrative

Final follow-up information: problem: the complaint reports increased nonspecific granular staining using the genpoint detection system with the genpoint hpv biotinylated probe for cervical cancer screening.The laboratory claimed that the nonspecific staining was severe enough to interfere with the pathologists' interpretation and potentially lead to a (b)(6) result and a misdiagnosis of the patient.No patient harm was reported despite several inquiries by agilent.The laboratory stated that they were unable to improve the test and therefore sent the specimen to another lab.This second lab was able to complete testing.In the absence of any other information about the patient and because the lab was able to complete the test eventually, agilent has concluded that no clinically significant indirect patient harm occurred at that time.Suggested root cause: root cause analysis was inconclusive.Post-retainers from the same genpoint detection system lot were tested in-house on both internal tissue controls and unstained slides from the customer; all stained within specifications.The customer did not return the affected kit.Analysis of the returned stained slides from the customer (negative control with positive stained patient sample) showed that background on the patient sample was slightly higher than seen on samples stained in-house, but their negative control was interpreted to be negative.Because the in-house testing was within specifications, and this complaint is the only complaint related to this lot with a total of 208 kits, it was concluded that the cause was not the kit, but might be due to a laboratory related issue.However, this was not determined for certain.Conclusions: since the root cause analysis suggests this issue may be laboratory related rather than kit related, and this appears to be a unique complaint to this customer, the chance of reoccurrence is low.Should this situation reoccur, a (b)(6) test leading to a (b)(6) diagnosis of (b)(6) and/or high grade cin/squamous cell carcinoma would be unlikely and should be easily detectable as the pattern of nonspecific granular staining is seen throughout the slide and not just within nuclei as is seen with the integrated pattern of (b)(6).A reoccurrence of this situation could cause a delay in test reporting; however, it should not be clinically significant, as other more specific hpv tests are available to detect genotype high risk virus if the assay was being used for this purpose.If ish was desired to allow correlation of morphology with the stain to help differentiate cervical intra-epithelial neoplasia i (cin1) from cinii/iii or squamous cell carcinoma, the delay would still be clinically insignificant, as additional kits from agilent could be shipped within 24-48 hours.Therefore, should this issue recur, it is considered improbable to lead to serious patient harm based on the information given above.

• Brand Name: GENPOINT TYRAMIDE SIGNAL AMPLIFICATION SYSTEM FOR BIOTINYLATED PROBES
• Type of Device: GENPOINT CATALYZED SIGNAL AMPLIFICATION SYSTEM
• Manufacturer (Section D): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria CA 93013
• Manufacturer (Section G): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria, CA 93013
• Manufacturer Contact: mani siravanta ; 6392 via real; carpinteria, CA 93013 ; 8055665462
• MDR Report Key: 5221852
• MDR Text Key: 31409920
• Report Number: 2022180-2015-00003
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: K0620
• Device Lot Number: 10092736
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1